cobas z 480

Roche cobas z 480 User manual

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  • What is the reagent expiry date based on?
    What can happen if an external storage device is improperly removed?
    What is the maximum number of error messages that can be displayed in the sample editor?
    What happens if you choose the Insert specimen button when the microwell plate is fully defined?
    How can I prevent incorrect work order entry?
    How can I prevent manual pipetting errors?
    What should I do if the LIS Host Query Mode checkbox and LIS connection was configured checkbox are both selected?
cobas
®
4800 System
Software Version 2.1
Known Issues for cobas® EGFR Mutation
Test
cobas® 4800 System
EGFR Known Issues
Roche Diagnostics
2 cobas® 4800 System, Known Issues · Version 1.1
Document information
Editor’s note Every effort has been made to ensure that the information contained in this manual is
accurate at the time of printing. Not all functionality described in this manual may be
available to all users. Roche Diagnostics International Ltd. reserves the right to make
any further required changes to software without prior notice. Such changes may not
immediately be reflected in this document.
Intended use
This document is for users of the cobas® EGFR Mutation Test on the cobas
®
4800
System.
Copyright © 2014 Roche Diagnostics International Ltd. All rights reserved.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS X, COBAS Z, and LIFE NEEDS ANSWERS are trademarks of
Roche.
All other trademarks are the property of their respective owners.
System-specific Known Issues
For system-specific issues, refer to the cobas
®
4800 System Known Issues document.
Manual version Revision date Main change
1.0 October 2013 First publication
1.1 May 2014 Added issue: If the LIS Host Query Mode checkbox and LIS
connection was configured checkbox are selected, then you
cannot load a work order file. (p. 5)
Roche Diagnostics
cobas® 4800 System, Known Issues · Version 1.1 3
cobas® 4800 System
EGFR Known Issues
Table of contents
List of known issues ...............................................................................................................4
Roche Diagnostics
4 cobas® 4800 System, Known Issues · Version 1.1
List of known issues cobas® 4800 System
EGFR Known Issues
List of known issues
# Issue Detail When can you encounter this problem Workaround
1
Reagent expiry date Reagent expiry date
clarification.
The reagent expiry date is based on the
Coordinated Universal Time (UTC).
Therefore, depending on the local time
zone relative to UTC, the local time for
reagent expiry could be offset by plus or
minus 12 hours.
For information only. Avoid using
reagent kits on the day on which
they expire.
2
Unrecoverable
software error
Unrecoverable software
error when an external
storage device is
improperly removed.
During a PCR Only workflow: if you
load or save a work order file from/to
an external storage device and then
remove the device, an unrecoverable
software error can occur.
Remove external storage devices
before starting a run or after the
run is complete.
3
Sample editor error
message display
In the sample editor,
more than two error
messages are not
displayed.
A maximum of two error messages can
be displayed at a time. If three error
messages are created when entering the
Sample ID, only two error messages
are displayed.
To view the other error messages,
resolve the visible error messages.
4
Sample editor Insert
specimen button
(editor context)
Insert specimen button
not available.
In the sample editor, you define the
maximum number of specimens i.e. a
full microwell plate. If you then choose
the Delete specimen button, the Insert
specimen button is not available (even
though the microwell plate is not full).
To display the Insert specimen
button after you choose the Delete
specimen button, choose another
field (e.g. in the Specimens field).
Alternatively, do not use the Delete
specimen button when the
microwell plate is fully defined. To
delete positions, use the Specimens
field. Once the position is deleted,
you can use the Insert specimen
button.
5
Sample editor Insert
specimen button (new
run context)
Unrecoverable software
error when you choose
the Insert specimen
button.
When creating a run for a full
microwell plate, you choose the Delete
specimen button from any kit (e.g. kit
#1), the Insert specimen button is
enabled for all kits (e.g. kit #1, 2, 3, or
4).
If you choose Insert specimen button
for a kit number other than the one
deleted (e.g. kit #3), the Insert
specimen button is still enabled for any
other kit (e.g. kit #1, 2, or 4).
If you choose the Insert specimen
button, an unrecoverable software
error occurs.
When the microwell plate is fully
defined, do not choose the Delete
specimen button. To delete
positions, use the Specimens field.
Once the position is deleted, use the
Insert specimen button.
6
Prevent incorrect work
order entry
The wrong test is
performed on a sample.
When you start a PCR Only workflow. Before starting a PCR Only
workflow, make sure that the
correct samples are selected for the
test.
Table 1 List of known issues
Roche Diagnostics
cobas® 4800 System, Known Issues · Version 1.1 5
cobas® 4800 System List of known issues
EGFR Known Issues
7
Prevent manual
pipetting error
Manual pipetting error
when transferring a
sample from tube to
tube or tube to
microwell plate.
When you transfer a sample from tube
to tube or tube to microwell plate.
There is no system surveillance for
sample tracking between the
sample tube and the microwell
plate. You can print the microwell
plate layout which includes the test
name and the barcode of the
ordered sample. Ensure that the
sample is transferred correctly from
the sample tube to the microwell
plate and that the work order file
correctly reflects the microwell
plate layout.
Make sure that you use the correct
sample volume and add an internal
control as described in the package
insert.
8
Prevent loading wrong
consumables
Reusing consumables or
using damaged
consumables.
When you load consumables on the
cobas
®
4800 System.
When loading consumables, check
that the consumables are not
damaged. Do not use damaged
consumables. Do not reuse
consumables.
9
Work order file load
functionality
When LIS Host Query
Mode checkbox is
selected, the option to
load a work order file is
unavailable.
If the LIS Host Query Mode checkbox
and LIS connection was configured
checkbox are selected, then you cannot
load a work order file.
To load a work order file, clear the
LIS connection was configured
checkbox under Utilities
> Configuration > System
settings, and then load the work
order file from the Select test dialog
box.
After the work order file has been
loaded, you can select LIS
connection was configured
checkbox again.
# Issue Detail When can you encounter this problem Workaround
Table 1 List of known issues
Roche Diagnostics
6 cobas® 4800 System, Known Issues · Version 1.1
List of known issues cobas® 4800 System
EGFR Known Issues
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