cobas IT 1000 Application

Release Notes Version 1.14 and 1.14.00.01

Release Notes Version 1.13
Release Notes PCommunicator 1.8
July 2010

Roche Diagnostics is pleased to announce the release of version 1.14.00.01 of the

cobas IT 1000 application in combination with PCommunicator 1.8. It corrects several known
issues of previous versions and refines existing functionality. Please place this release note in the
front of your cobas IT 1000 application Instructions for Use, for easy reference and
documentation.

This document contains short descriptions of the issues addressed and features refined or added
in versions 1.13 and 1.14.00.01 as version 1.13 was not globally rolled out.

Release Notes 1.14 v00 Page 1 / 20

Release Notes Version 1.14 and 1.14.00.01
New Features
Display Column with assigned Units in Operators > Individuals
The Operators > Individuals component was enhanced to show the unit(s) operators are
assigned to. It is also possible to filter by assigned unit(s). When using the "Print" function, the
assigned unit(s) column will be displayed together with the other columns.

Base L-J Statistics on Date Range

The statistics supplied with a Levey-Jennings graph in the Quality Control > L-J Graph and
Quality Control (RiliBäK) > L-J Graph components will be calculated based upon the date range
set in the screen.

Refined Functionality
Support "Consilia" ADT mode for Patient Identification Support on Instruments across All
Instrument Types
Description:
The application fully supports non-Accu-Chek Inform family and ICA instrument functionality
in regards to patient identification support also in a multi-source ADT environment (i.e.
"Consilia workflow").
The application will do the following:
a) If “Consilia” is selected for the General Setting “HCA Installation”, the site ID of the
instrument will be removed from the patient IDs sent as part of a patient list to connected
instruments also for non-Accu-Chek Inform family instruments.
b) If “Consilia” is selected for the General Setting “HCA Installation”, the complete patient ID
(site ID of the instrument and instrument patient ID) will be taken into consideration when
querying the database for patient demographics to be able to respond to instrument patient
queries also from ICA instruments.

Release Notes 1.14 v00 Page 2 / 20

Addressed Issues – Application Fixes
Flagged Patient Results due to missing QC Result (RiliBäk)
When only 1 level was defined for a QC material of a RiliBÄK 2008 POCT mode instrument, the
application did not only check the current QC interval on whether a QC was done, but also the
preceding QC interval (although this should be done only if the QC material(s) applicable for
this test have more than 1 level defined).
Fix: Only the current QC interval is now checked in this scenario.

Overwritten Settings (RiliBäk)

Some customer/service defined settings (RiliBäK Test mappings) where overwritten while
installing version 1.13.
Fix: The installation routine does not touch such settings any more.

Precision Defined for a Test Ignored When Sending Results to the LIS
The results were sent to the LIS without proper formatting. The set up precision was not taken
into account and leading zeros were missing.
Fix: The precision as defined in System > Tests > Decimals is taken into account when sending a
result to the LIS. Also leading zeros (where applicable) are sent.
Example:
Result with a defined precision of two decimals of .23423 will be sent as 0.23 and a result of 123.2
will be sent as 123.20.

Patients Blocked because of QCE Alarms, with good QC Results.

Patient results were blocked with QCE alarms although the related QC results were correct. This
was caused by the way the application handled QC periods.
Fix: The internal processing of QC periods has been refined to correctly process QC and patient
results independently of the order in which they are received.

Result Query Screen isn't displaying Results

If a large number of results need to be displayed then the error message ‘An error has happened
while processing this page.’ may have been displayed. This was caused by the underlying
database query timing out.
Fix: The way the database is queried for results was refined. This also means that the delay until
results are displayed is reduced for a given number of results/more results can be held
concurrently.

Release Notes 1.14 v00 Page 3 / 20

Missing Measurement Unit for Ca++
Until now "meq/L" could not be selected as a measurement unit (required for e.g. the Ca++ test
when Radiometer instruments are connected) in the application. A service engineer would have
to add it manually if required.
Fix: The unit meq/L was added to the system units.

Error on Clicking in Warning Message "New instruments pending"

When the warning message "New instruments pending" was clicked in the warning area, the
error "An error has happened while processing this page" was shown.
Fix: The link to the related screen was corrected.

Unknown ADT Events are Treated as Discharge

ADT Events which are not mapped in the host configuration are treated as a discharge.
Fix: The corresponding message will show the error ‘39006@@ZDN Unknown ADT type’ in the
message broker. The ADT message will not be processed further.

Patient List is not Uploaded to Accu-Chek Inform II Instruments if Patient ID 2 or 3 is Used

If the database field PatientAux was mapped to a different HL7 ADT field than the Patient ID 1
field the Patient list sent to Accu-Chek Inform II instruments is not automatically updated.
Fix: The issue was fixed and the mapping does not have an effect on the patient list download
anymore.

Wrong Amount of Excluded Results Displayed on the Levey-Jennings Graph Report

The value 'Excluded' of the report Levey Jennings Graph shows a wrong number of results.
Fix: The way the amount of excluded results is calculated was corrected and the proper value is
now shown.

Not possible to Use the same Lot Number for different Materials of the same Instrument
The application in general allows the use of same lot number for different materials for the same
instrument type. However doing so lead to incorrect statistics in the reports Material Lot
statistics, QC Summary (by Unit and Instrument) and QC Summary (by Instrument Type and
Unit) of the QC and linearity results as e.g. QC level 1 and linearity level 1 were counted together
although they should have been counted separately.
Fix: The reports have been refined to show the correct lot statistics.

Release Notes 1.14 v00 Page 4 / 20

Carriage Return and Line Feed in HL7
If a line-break was entered as part of a comment in the application this line break was passed on
to the HL7 message when sending the related result to a LIS.
Fix: The default host configuration has been updated with a setting which replaces carriage
return and line feed characters with spaces for the comments field.

Blocked Messages in Message Broker

Messages in status processing were found in the message broker where the message body did not
contain information. Such messages stopped other (correct) messages from being processed.
Fix: The status of such a message will be changed to Error and the message will not be further
processed.

The copied Configuration does not contain the Tests deactivated in the Source Configuration
Deactivated tests of an instrument configuration were not copied into a new instrument
configuration when using the ‘Copy From’ button.
Fix: The copy of an instrument configuration will be an exact copy of the source instrument
configuration.

Alarms Monitor (RiliBäK) does not show QC Timing related RiliBäK Alarms on Patient Results
The Alarms Monitor (RiliBÄK) in RiliBäK 2008 mode does not show QC timing related alarms
on patient results (only the ones related to accepted QC results outside range/allowed deviation),
hence the link is lost between the number of RiliBäK alarms warned about (the warning includes
the ones on QC timing) and the RiliBäK alarms that can be acted upon.
Fix: The Alarms Monitor (RiliBäk) now shows all relevant alarms.

Tuning of QC Tables from the Service & Maintenance Tool

The table tuning functionality listed one table that should not be tuned (qc.tQcRange). If tuned
it could mean that test lots are no longer sent to instruments.
Fix: The table qc.tQcRange was removed from the list.

Release Notes 1.14 v00 Page 5 / 20

Missing Alarm Mappings in Default Data
The following alarms mappings were missing in original installations done with version 1.11 (the
mappings when an earlier version was upgraded to version 1.11).
Instrument Type Alarm Action
B1200 FEC Error
MEDAP FMWE Error
B400 FEC Error
ACI2 CFAC Information

Fix: The missing mappings have been added.

Cobas IT 1000 Version Mismatch Detection

Cases were reported where the components of the cobas IT 1000 application were running on
different versions.
Fix: The login screen of the cobas IT 1000 application shows the current software version. If a
mismatch of application component versions is detected then this version number is shown in
red and an warning message is shown when logging in. Usage of the application in such a case, is
possible, but may be disturbed due to version mismatches. It is strongly recommended to not
use the system in such a condition and to call Roche support for fixing the issue.

Validation Status Filter Criteria not applied for the Corrective Action Log
The filter criteria ‘Reject’ or ‘Accepted’ for the Corrective Action Log is not applied and
therefore the report shows all results independent of the selected validation status filter.
Fix: The filter works now as expected.

Two Spelling Mistakes in the Application

The two option "Always send Patient List to instruments" and "Always send Operator List to
instruments" are wrongly translated to German.
In Operator > Certificates > Types > Maintenance there is a spelling mistake in a warning
message.
Fix: The spelling mistakes have been fixed.

Release Notes 1.14 v00 Page 6 / 20

Automatically Validated QC Results are sent to the LIS without Comments
When a QC result was received from the instrument and was automatically validated, it was sent
to the host without the comments assigned to it.
Fix: The processing of the QC result has been changed so that comments will be sent to the LIS
as well. However, this fix applies to QC results received from instruments only. Comments on
manually entered QC results will only be sent to the LIS if the result needed to be validated
manually. A separate ICATT was opened in order to handle the issue.

Mean always rounded to 2 Decimals

The displayed mean in the L-J Chart, L-J Review and Cumulative Chart screen was always
displayed with 2 decimals regardless of the precision defined for this test.
Fix: The Mean, Expected Mean and SD are now rounded to the number of decimals defined in
System > Tests (plus 1). CV and Bias are rounded to 2 decimals.

Result Value Replaced by Comment Text

When a result is equal to a comment code (as defined in System > Coded Comments) or the
comment code starts with the result value, the application replaces the result value with the
comment text.
Fix: The result is now reported properly.

Documentation Changes
Safety Information in Manuals does not Reflect Latest Standards
The safety information in the manuals are updated to reflect the latest standards within Roche.
E.g. Safety Classifications were added and colored icons are used.

Insufficient Information on Instrument Type Related Functionality

An additional chapter has been added to the operator manual with information on how specific
application functionality applies to certain instrument types. This chapter is intended to cover
more instrument types with further releases of the manual.

No Information on Supported Characters for Operator IDs

The operator manual was updated to include the information about supported characters for
operator IDs.

Update Service Manual with regard to Automatically Exporting and Purging Audit Log Data
The service manual states that the automatic exporting and purging of audit log data is active by
default and needs configuration.

Document Procedure 'Tune Tables' in the 'Service and Maintenance Tool'

Additional steps were added as prerequisites to be done before starting the tune tables procedure.

Release Notes 1.14 v00 Page 7 / 20

Update Firmware Update Procedure
Additional steps for the update of instrument firmware via the cobas IT 1000 application were
added.

How to Configure the System so no QC is Expected for Calculated Tests

The manual was extended with the configuration settings required to make sure that the
application does not expect QC results for calculated tests.

Database License for a Shadow Server

The shadow server configuration chapter was extended with database license order information.

Update Prerequisites for Hosting Server

The manual was updated to reflect that the Microsoft Server 2003 Operating System has to be
installed with default settings.

Release Notes 1.14 v00 Page 8 / 20

Release Notes Version 1.13 – April 2010
New Features
Introduction of a Service & Maintenance Tool
The Service & Maintenance Tool provides different service and maintenance functionalities
which are not covered by the application and which had to be performed manually before.

Improved Handling of Audit Log Data

The following General Settings were added to specify the criteria on how to handle log data in
regards to automatic export and purging from the database: “Export log data before purging”,
“Number of days after which to purge other log data”, “Number of days after which to purge
Audit Log data” and “Path for log data export”.

Sample Statistics by Panel Report

An additional report “Sample Statistics by Panel” has been added to determine the usage of
instrument consumables and its distribution within the institution by test panels (as an
optimization towards blood gas usage).

Monthly Feedback Report

An additional monthly feedback report has been added which returns the information sorted by
unit, instrument type, instrument, test and calendar month. The report shows only data on tests
used in QC and/or linearity material definitions. For each (sending) unit (belonging to the same
site the requesting user is currently logged in), instrument, test and calendar month, one page of
report is produced. It is possible to enter the name of the report as shown on the individual
pages. One or several calendar month can be selected at a time by using a custom filter. The data
can be filtered by the following criteria: unit, instrument type, instrument name, instrument
serial number, and test abbreviation. It is possible to define a number of operators (0 to 5) and
patients (0 to 5) for which specific statistics are reported; this part of the report is intended for
generic operators and patients. For each page the following information is shown in a sub-
header: Site name, the (sending) unit, calendar month, instrument type, test abbreviation and
the combination of instrument name & serial number. On each page there is a statistic on
performed patient tests and performed QC tests as well as a Levey-Jennings graph on performed
and accepted QC tests. On each page there is an operator and patient activity statistic table for
the operators or patients selected in the filter criteria. Also a space to manually put information
on observations related to the report has been included.

Test Statistics (by Unit and Instrument type) Report

An additional report “Test Statistics (by Unit and Instrument type)” has been added which lists
the number of tests for the following result types: Patient (sum), Patient (run as STAT), QC,
Linearity and the sum of Patient, QC and Linearity (all of them listing the numbers of accepted
and of all results separately) for a timeframe to be set in the filtering options.

Release Notes 1.14 v00 Page 9 / 20

Refined Functionality
Direct "Print" Button for Quality Control > L-J Review
This screen was updated to offer direct printing capabilities similar to the Quality Control > L-J
Chart screen.

CV and Bias Shown as Percentage

The columns CV and Bias in L-J Review, L-J Chart and Cumulative Chart screens are now shown
in percentage.

"Expected mean" Shown in Graph Statistics

A new column “Expected Mean” for the L-J Review, L-J Chart and Cumulative Chart screens in
the statistics area was added.

Tree not Collapsed after accepting L-J Graph

When a graph is accepted in Quality Control > L-J Review all nodes previously expanded are still
expanded and none of the expanded nodes are collapsed.

Instrument drop-down menus Sorted by Active/Inactive and Alphabetically

In drop-down menus containing instrument names or instrument serial numbers the entries are
now sorted first by whether the instrument is active (active ones shown first) or inactive and
second alphabetically.

QC Statistics in "Levey-Jennings Graph" Report Enhanced

The "Levey-Jennings Graph" report accessible from Reports > Reports Inquiry was enhanced to
include the following items: Deviation expressed in percent for each value, comments related to
each result in the list of accepted results and lists of rejected and pending/on hold QC results.
The following statistics were also included: N (number of accepted QC results displayed in the
graph), Mean (calculated mean of the values shown in the graph in the unit of the test with a
precision of 1 digit more than set up for this test in System Tests), SD (standard deviation of the
entire population of results shown in this graph, in the unit of the test with a precision of 1 digit
more than set up for this test in System Tests), CV (CV of the entire population of results shown
in this graph, as a percentage with a precision of 1 decimal digit). These elements are combined
with the existing counters and offered for a "Lot (Combination) Life Time Summary" and a
"Date Range Summary".

Release Notes 1.14 v00 Page 10 / 20

Addressed Issues – Application Fixes
Communication Error ICA - ACB
A mismatch between the ICA global LDFIN and LDIA blocked patient results from being
processed. A service action was previously required to resolve the issue.
Fix: The code was changed in order to fix this issue.

Performance Problems due to "Tuning Table Statistics"

Performance issues were reported because of the way the tune table statistics process was
implemented.
Fix: The procedure was updated and the tuning process was moved to the service and
maintenance tool.

Host Interface Issue Triggered by Accu-Chek Inform II Configuration Setting

Patient admit did not work if the Accu-Chek Inform II device configuration setting “Incoming
Patient List”(Instrument>Configurations>Device Configuration>Patient>Incoming Patient
List) was set to “Without Unit and Instrument Unit”.
Fix: The code was changed so that the configuration does not have an impact on the host
interface.

Recertification Report Takes 60% of CPU and runs for Several Days
Under certain circumstances it happened that the process calculating the data for the
recertification status report allocated most of the server’s memory and influenced negatively the
general performance of the application. The calculation of the data used by the reported lasted
for several days.
Fix: The daemon which was calculating the data for the recertification report has been removed.
Currently the calculation is performed at report generation time and only the data to be
included in the report is calculated.

Auto-Recertification Process Very Slow, Temporal Loss of Operator Certification Possible

Under certain circumstances it happened that operators were not recertified because of the poor
performance of the recertification process.
Fix: The recertification process was completely rewritten.
Test/Sample Statistics Report Counts Rejected Samples Incorrectly
The Test/Sample Statistics (by Unit and Instrument Type) report counted rejected samples
incorrectly. Therefore it happened that the report data also showed the total number of samples
incorrectly.
Fix: The query calculating the number of rejected samples was corrected.

Release Notes 1.14 v00 Page 11 / 20

Number of Alarms in RiliBÄK 2008 Alarms Monitor and Related Warning
The number of RiliBÄK 2008 alarms shown in Alarms Monitor screen and the related warning
was incorrect. Therefore there were alarms the POCC was warned about but could not
acknowledge and alarms were shown that did not need acknowledgement.
Fix: The queries defining the content of the RiliBÄK 2008 alarms monitor and the query
warning on the amount of unacknowledged alarms were fixed.

Formatting Issues in Test/Sample Statistics Report

The report had several formatting issues.
Fix: The layout of the report has been changed

Missing Alarm Flags on Patient Results and Wrong Reference Ranges

If some tests were configured for a female/male pair of reference ranges, and other tests were
configured for generic sex reference ranges, then, depending on which test result was received
first, the application may have applied wrong reference ranges when sending them to a LIS.
In addition, the alarms belonging to this first processed test result might be applied to other tests
that have been configured with gender specific reference ranges. This behavior may result in a
missing or false alarm.
Fix: The code was changed in order to fix this issue.

Error When Clicking on [Export] in "Audit Log Backup" with a Two-Digit-Year Date Format
If the date format was set to a format with two year digits only (e.g. yy-mm-dd) an exception was
raised, if clicking on [Export] under "Utilities > Audit Log Backup".
Fix: The screen was removed from the application as the same (and enhanced) functionality was
added as a new background process configurable via System > General Settings (see New
Features - Improved Handling of Audit Log Data).

QC Results with Leading or Trailing zeros are Not Recognized as Being Numeric
Numeric QC results with leading or trailing zeros were treated as alphanumeric results and
hence flagged as being incorrect although they may be within range/allowed deviation.
Fix: The way of recognizing the value type was fixed.

Missing Mapping of Specific Globals to Cachetemp Database

In some cases it happened that temporary data was still stored in the ACB database instead of
the Cachetemp database. This resulted in a increased amount of journal files.
Fix: The process responsible for introducing the proper mapping definitions is always launched
during installation.

Release Notes 1.14 v00 Page 12 / 20

Host Interface Issue Triggered by CoaguChek XS Plus/Pro, cobas h 232 and HemoCue 201 DM
Connection
The (re-)definition of instrument type information for CoaguChek XS Plus/Pro, cobas h 232 and
HemoCue 201 DM instrument types led to an application usage of patient list handling that
resulted in the inability to add, edit or delete patient data entries associated with instruments of
the abovementioned types via the user interface or an ADT feed.
Fix: The code of the patient list handling was reworked to fix the issue.

Documentation Changes
Service & Maintenance Tool Instructions for Use
Instructions for Use were created for the Service & Maintenance Tool. It contains the description
of the functionality available to the “customer” user.

Chapter Overview Pages Incorrect In Online Help

Some overview pages had an incomplete list of sub chapters. With the sub chapters page
numbers were shown.
Fix: The online help was changed in order to fix this issue.

In User Interface: Workspace Online Help Page Letters B to F Not Visible in Description Below
Image
In the page "Understanding cobas IT 1000 : User Interface : Workspace" of the Online Help, the
letters B to F were not visible within the description below the image.
Fix: The cobas IT 1000 instructions for Use have been changed in order to fix this issue.

Release Notes 1.14 v00 Page 13 / 20

Release Notes PCommunicator 1.8
New Features
Include date-of-birth into Patient List sent to Accu-Chek Inform II Instruments
Patient list for Accu-Chek Inform II will now contain the date of birth value for each patient.
- Support minor Features of Accu-Chek Inform II FW 2.0
- The operator name and the expiration date will now be sent with the operator list.
- The possibility to configure the 'Download Lockout' and 'Power Save Mode' has been added.
- In the application it is now possible to choose if patient ID entry/selection is confirmed by
displaying the patient name, the patient date of birth, both or if no confirmation is required.
- It is possible to process the Temperature Warning flag if sent by the instrument.
- The QC ranges and expiration date transmitted by the instrument are taken from the
“default” elements if a new lot information has been received form the instrument.
- The reporting of Strip Lot Number (STE) and Release Upload Lockout (RUL) events as well
as Error 11521 has been added.
Simplify PCommunicator Installation Process
There is now only one installation process.
Ensure that Configuration is sent to CoaguChek XS Plus/Pro Instruments after Patient List.
Implemented to prevent an instrument issue (see instrument Clarify cases GC-0334364 & GC-
0345059).
Include 'QC Time (hh:mm') in cobas h 232 Configuration
An option to configure the time of day when the QC Lockout should be performed has been
added.

Release Notes 1.14 v00 Page 14 / 20

Support additional Instrument Functionality introduced with Firmware Version 02.02.00 for
CoaguChek XS Plus/Pro
- Allow Finnish to be selected as instrument language in the configuration.
- It is possible to configure whether comment entry/selection after having performed a
measurement shall be optional, required or required for out of range results.
- It is possible to enable custom QC range checking.
- If custom range checking is enabled, it is possible to configure the maximum allowed
deviation as a percent value between 0 and 22.5 also the QC target value shall be shown with a
QC result.
- To reflect changes in the instrument naming, the “Lockout” heading in the instrument
configuration has been changed to “QC settings”
Support Usage of additional Languages for cobas h 232
Allow Polish or Greek to be selected as instrument language in the configuration. It is required
to update the cobas h 232 with the according language packs first.
Preparation for EAP WLAN Security for Accu-Chek Inform II FW 3.0
Accu-Chek Inform II instruments with at least firmware 3.0 support EAP for WLAN connection.
PCommunicator supports the transmission of such files to the Instrument.
Reset supported for additional instrument types
For Accu-Chek Inform II and CoaguChek XS Pro instruments it is possible to reset (i.e.
baseline) the information sent to the instrument by clicking the “Reset” button in Instruments >
Status. Also after a firmware update the “reset” will be trigged.
This auto-reset after firmware update applies to cobas h 232 and CoaguChek XS Plus
instruments as well.

Addressed Issues – Application Fixes

patientnamemaxlength Default Setting for CoaguChek XS Plus
Default setting has been set to 20.
Expiration Date from New LOT Information is Empty in Some Cases (Accu-Chek Inform II)
The issue that the expiration date for new QC lots was not received has been fixed.
PCommunicator 1.8 Basic Configuration Settings
The installer has been extended to apply default settings to configuration settings only if they are
explicitly defined to be set. Otherwise previously set configuration settings still apply.
operatornamemaxlength Default Setting for Accu-Chek Inform II
Default setting has been added and set to the instrument limit.

Release Notes 1.14 v00 Page 15 / 20

Limitations – General Issues
The limitations listed below have not yet been addressed.

Operator -> Certificates (Per Site)

A certificate can only be used in one site. If a certification is assigned to an operator assigned to
units belonging to more than one site, the certification is visible on all related sites. However, if
an operator assigned to only one of the sites is added to the certification, operator certifications
of operators exclusively assigned to the other site, are deactivated.
Workaround: Create site specific Certificates.

Similar Workgroup Names

When filtering in Operators > Certificates > Types > Maintenance > Certifications (Add
Individuals) by workgroup, operators are also shown under workgroups with names starting
alike their own (e.g. a member of workgroup CH22 would also be shown for a workgroup CH2).
Workaround: None.

System Startup
When stopping Caché, processes may continue to run; Caché can then only be started
successfully after rebooting the server.
Workaround: Restart the server.

Database Backup
Weekly backups are not done when set to be executed on Sunday.
Workaround: Configure a day other than Sunday.

Caché Lock Table Full Due to Patient Cleaner Daemon

The Patient Cleaner is causing performance issues when deleting patients with many results
(>1000)
Workaround: Deactivate the Patient Cleaner daemon.

Results of Different Instruments for the Same Patient Assigned to the Same Sample ID
If cobas IT 1000 receives at exactly the same time results from different instruments for the same
patient, it will assign both measurements to the same Sample. Therefore if the user chooses the
option "Sample" in the "Tests - Test Validation", the result screen "Tests - Test Validation -
Results Query" shows a mixture between them.
Workaround: None.

Error “<INVALID OREF>zNextOrderID” Shown in Message Broker Monitor

In special circumstances it can be that results are blocked and can not be delivered because of an
internal issue.
Workaround: Reopen the message manually in the message broker monitor.

Release Notes 1.14 v00 Page 16 / 20

Comments are not Properly Displayed
Until version 1.07.04 the reports All Results (chronological / by Instrument and Unit) were
displaying all comments of a specific result, no matter how many lines were used. Since 1.07.05
the amount of characters shown is limited.
Workaround: None.

Expired QC Lot Does Not Trigger MQC Alarm

The application does not flag results with an MQC alarm (QC material lot not valid) if the used
material lot was expired.
Workaround: Warning on material lot being expired needs to be activated.

Failed Database Transaction Rollback

It may happen that a database transaction rollback fails which leads to a database logic
inconsistency Database table indexes could be damaged.
Workaround: The intervention of a service engineer is required to solve the issue.

Release Notes 1.14 v00 Page 17 / 20

Limitations – Reports
Issue with the Reports ‘All Results (Chronological)’ and ‘All Results (By Unit and Instrument)’
The reports ‘All Results (Chronological)’ and ‘All Results (By Unit and Instrument)’ shows
always mmol/L for QC results and no unit for manually entered patient results.
Workaround: None.

Resource Problem with Long Reports - Report Cannot Be Created Several Times
A report containing very much data temporarily cannot be created several times in rapid
succession, showing the error "unable to create report, use tighter filter criteria". This behavior
was discovered on the "recertification status report" as well as "POCT monthly feedback report".
Other reports may also be affected.
Workaround: None (Microsoft IIS will release the blocked memory automatically after a while).

Release Notes 1.14 v00 Page 18 / 20

Limitations – Instruments
ITC Hemochron Signature Jr. Reports the ‘<’ Sign Instead of a Value
When a result received from ITC Hemochron Signature Jr. contains a quantitative value
preceded by a space and the less sign ‘< ‘ (for example APTTcit-P = < 20 sec), the system
interprets the value following the blank space as a result. In this situation cobas IT 1000 displays
a “<” in place of a real value. The value following the second blank space is interpreted by the
system as units of measurement and then the quantitative value sent by the instrument takes the
place of the units.
Workaround: Set up "Alphanumeric result modifications" to automatically replace received "<"
characters with the expected value.

Do Not to Change Test Abbreviations (Glu and Glu2) Used by Accu-Chek Inform and Accu-
Chek Inform II Instruments
After changing the test abbreviation in System> Tests the system may report QC results in the
secondary units of the measurement and/or strip and QC lots are not retained on the
instruments.
Workaround: Do not change the Glu and Glu2 test abbreviations.

No QMDM Evaluation Done When Adding Non-POCT Instruments (RiliBäK Only)

If a new non-POCT instrument was introduced using the “Add” button, no QMDM evaluation
will be done
Workaround: Double click the instrument record in Instruments > Individual Setup once more
and click the OK button to save the configuration. This will update the related field in the
database.

Instrument Configuration for Sysmex KX-21N and HemoCue 201DM Shows Wrong
POCT/NON-POCT Settings (RiliBäK 2008 Only)
Instrument configurations for Sysmex KX-21N and HemoCue 201DM show the wrong POCT
setting in Instruments > Configurations. This is because that setting did not exist at the time of
driver implementation.
Workaround: Run script DriverInformationRollup_V03.vbe after the installation of such a
driver.

HemoCue 201 DM does not Receive all Control Lots

The cobas IT 1000 application does not send all active control lots to the HemoCue 201 DM
instruments.
Workaround: Have only the currently used control lot active in Material > Maintenance.

Release Notes 1.14 v00 Page 19 / 20

Patient List for Accu-Chek Inform II Instruments not Complete
If ‘Instrument Unit Only’ is selected for the instrument configuration setting
>Patient>Incoming Patient list then some admitted patients will be missing on the patient list
sent to the instruments.
Workaround: There are two workarounds available:
1. Change the above configuration setting to "All patients". This workaround is limited to sites
were only a small number of patients are admitted in total.
2. Start the Patient Tracking daemon every 5 minutes.
Operator List not Complete for Instruments where Firmware was Updated
The firmware update clears the memory of the meter. This is not reflected in the cobas IT 1000
application and therefore the list may not be complete.
Workaround: Assign meter to a unit without operators and back or wait until full upload is done
(done once a day in default configuration).

Limitations – Host Connectivity

Reconnect of HIS after Dropped Connection Not Possible
If an HIS system disconnects from cobas IT 1000 it may happen that it will not be possible to
connect again.
Workaround: Restart the cobas IT 1000 server.

Release Notes 1.14 v00 Page 20 / 20