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Roche cobas z 480, cobas x 480 User manual

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1
cobas
®
4800 System
Software Version 2.1
Known Issues
Roche Diagnostics
cobas® 4800 System · Software version 2.1 · cobas® 4800 System · Known Issues · Version 1.1
2
Document information
Editor’s note
This document is for users of the cobas
®
4800 System.
Every effort has been made to ensure that the information
contained in this document is accurate at the time of
printing. Not all functionality described in this document
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 The system is intended to be used as a diagnostic or
screening system providing sample preparation,
amplification and detection of specific targets from
human samples.
The system is to be used by laboratory professionals
trained in laboratory techniques and by instruction on the
use of the system.
Copyright © 2007-2014 F. Hoffmann-La Roche Ltd. All rights
reserved
Trademarks The following trademarks are acknowledged:
COBAS, COBAS Z, COBAS X, and LIFE NEEDS ANSWERS
are trademarks of Roche.
All other trademarks are the property of their respective
owners.
Test-specific Known Issues For test-specific issues, refer to the test-specific Known
Issues document.
Manual version Software version Revision date Main change
1.0 2.1 September 2013 First publication
1.1 2.1 October 2014 Updated issues. Split into 3 sections.
Roche Diagnostics
cobas® 4800 System · Software version 2.1 · cobas® 4800 System · Known Issues · Version 1.1
3
T
able of contents
List of known issues for the cobas
®
4800 System. . . 4
List of known issues for the cobas x 480 instrument 6
List of known issues for the cobas z 480 analyzer. . . 8
Roche Diagnostics
cobas® 4800 System · Software version 2.1 · cobas® 4800 System · Known Issues · Version 1.1
4 List of known issues for the cobas
®
4800 System
List of known issues for the cobas
®
4800
System
# Issue Detail When can you encounter this problem Workaround
1
Unrecoverable
software error
during startup
Unrecoverable
error if the
cobas
®
4800
software is started
immediately after
Windows logon.
If you start the cobas
®
4800 software
before Windows and Oracle have
finished initializing, an unrecoverable
error occurs.
After starting the computer, wait for
at least 30 seconds before starting
the cobas
®
4800 software.
2
Unresponsive
software while
printing
The cobas
®
4800
software becomes
unresponsive when
printing message
logs while sending
results to LIS.
If you print log files from Messages
> Log files while results are being sent
to LIS, the cobas
®
4800 software
becomes unresponsive. You must be
logged on as an administrator.
If this error occurs, shut down the
cobas
®
4800 software using the
Windows Task Manager
(Ctrl+Alt+Del). Then restart the
cobas
®
4800 software.
After the restart, check the results
view to see if the specimen were
uploaded to LIS. If the specimen were
not uploaded, resend them.
3
Unresponsive hand-
held barcode reader
The hand-held
barcode reader
becomes
unresponsive
during reagent
loading.
Issue that may occur when scanning
reagents.
If possible, manually enter the
reagent barcodes to continue the run.
Before the next run, restart the
cobas
®
4800 software to reset the
hand-held barcode reader.
If you cannot manually enter the
reagent barcodes, abort the run and
restart the cobas
®
4800 software.
4
Leading and trailing
spaces
Leading and
trailing spaces are
truncated on
specimen
barcodes.
When you are creating a work order file
or loading specimens.
Do not use blank spaces at the
beginning or end of specimen
barcodes.
5
Incorrect LIS upload
message
Incorrect number
of LIS results sent
is displayed.
If you upload more than 5 runs at the
same time, an incorrect number of LIS
results sent may be displayed on the
LIS results sent dialog box.
Only a display issue. The results are
correctly sent.
Check the results view to confirm the
status of the specimen upload.
Upload results to the LIS daily.
6
Incorrect LIS upload
message
Number of LIS
results sent is not
displayed after
repeat.
When resending results to LIS, the LIS
results sent dialog box is not
displayed.
Only a display issue. The results are
correctly sent.
Check the results view to confirm the
status of the specimen upload.
7
Incorrect LIS upload
status
The Result sent
column status for
LIS, only displays
last status.
In the Result sent column, only the
most recently transmitted status is
displayed.
For information only.
8
Sending results to
LIS
If the Send results
to LIS button is
pressed multiple
times, the same
results are sent to
LIS multiple times.
A result could not be successfully
uploaded to LIS. To resend the result
again, you choose the Send results to
LIS button multiple times. After the
connection is re-established, multiple
results are sent and the status does not
change.
If a result cannot be sent to LIS (e.g.
due to communication issues), do not
choose the Send results to LIS
button again. The results are sent
automatically during the next
available connection.
y List of known issues for the cobas® 4800 System
Roche Diagnostics
cobas® 4800 System · Software version 2.1 · cobas® 4800 System · Known Issues · Version 1.1
List of known issues for the cobas
®
4800 System 5
9
Incorrect LIS
download alarm
message
Alarm message for
LIS work order
download failure is
incorrect.
If LIS is disconnected when
downloading a work order file, the
alarm area only states one of the work
orders that failed to download and not
all of them.
Verify LIS connection and repeat the
work order download.
10
Error sending
results to LIS
Unrecoverable
error when
communicating
with LIS.
When sending results to LIS and an LIS
work order download occurs at the
same time, an unrecoverable error may
occur.
From the pop-up window, restart or
shutdown the cobas
®
4800 software.
Allow the cobas
®
4800 software to
finish sending results to LIS before
requesting a new work order
download.
11
Send results to
LIS button
The Send results
to LIS button is
unavailable.
If you are uploading results to LIS and
the connection is lost, the Send results
to LIS button remains unavailable even
when LIS connection is restored.
To enable the Send results to LIS
button, exit and restart the
cobas
®
4800 software.
12
Cannot import work
order file
Ability to import
work order file is
disabled.
When the LIS Host Query mode is
activated, the ability to import a work
order file is disabled.
To import the work order file,
temporarily disable the LIS.
Alternatively, the work order can be
created when you start the run.
13
CommServer status
update
Stop CommServer
Service not
reflected in LIS
Status display.
When the CommServer Service is
stopped, the LIS Connection status
under Overview > System overview
may not be updated and the run is
stopped after loading samples.
Restart the cobas
®
4800 software.
14
Error after removing
external storage
device (ESD)
Unrecoverable
error when saving a
work order file after
the ESD is
removed.
After loading a work order file from an
ESD and then the ESD is removed.
When the ESD is removed and you
choose to save the work order file, an
unrecoverable software error may
occur.
Save the work order file onto a folder
in control unit.
15
Result view loading
time
Result view loading
time is longer in
software version
2.1 than in software
version 1.x.
When you view test results in the result
view tab.
To improve the result loading speed,
create filters (e.g. date range, sample
type, test type) in the result view.
You can also increase the frequency
of archiving and purging the
database.
# Issue Detail When can you encounter this problem Workaround
y List of known issues for the cobas® 4800 System
Roche Diagnostics
cobas® 4800 System · Software version 2.1 · cobas® 4800 System · Known Issues · Version 1.1
6 List of known issues for the cobas x 480 instrument
List of known issues for the cobas x 480
instrument
# Issue Detail When can you encounter this problem Workaround
1
Unresponsive
software
Software
unresponsive when
starting a run.
If the cobas x 480 instrument cover is
open before a run is started, a warning
is displayed. If you choose the Abort
button, another window is displayed
and the cobas
®
4800 software
becomes unresponsive.
Before starting a run, make sure that
the cobas x 480 instrument cover is
closed. If the software becomes
unresponsive, shut down the
cobas
®
4800 software using the
Windows Task Manager
(Ctrl+Alt+Del). Then restart the
cobas
®
4800 software.
2
Incorrect error
message
X10 flag incorrectly
displayed.
When empty or partially filled tip racks
are loaded from another cobas
®
4800
System.
Only a display issue for X10 flag in
specific cases.
Do not use empty or partially filled tip
racks from another cobas
®
4800
System. Do not manipulate the tips
on partially filled tip racks.
3
Incorrect sample
carrier error
Sample carrier
identification error
is incorrectly
reported.
When "/" is used as a specimen
barcode character, the cobas
®
4800
software incorrectly generates an error
stating the sample carrier could not be
identified.
Run must be aborted. Choose the
Abort button, manually remove the
sample carriers, exit, and then restart
the cobas
®
4800 software.
Choose the OK button to
automatically unload and load the
sample carrier.
4
Error reading
reservoir barcode
The run cannot be
continued as the
reservoir barcode
cannot be read on
the cobas x 480
instrument.
When the cobas x 480 instrument
cannot read the reagent reservoir
barcode.
Run must be aborted. Choose the
Abort button, manually remove the
sample carriers, then start a new run
with new consumables.
5
Partial used tip rack The tip pickup
algorithm may
generate multiple
partially used tip
racks.
After multiple 96 batch size runs are
performed continuously.
Load partial pipette tip racks when
performing smaller batch sizes runs
(e.g. 24, 48 and 72) in between the 96
batch size runs.
6
"[" in code 128 not
supported
Character "[" in
code 128 is not
supported for the
specimen barcode.
It might lead to run
abort.
When a specimen barcode with
character "[" is loaded onto the
instrument.
Do not use "[" as a specimen
barcode.
7
Barcode scanning
reload speed
The barcode
scanning reload
speed during error
recovery is reduced
in software version
1.x but not in
software version
2.1
If there is a barcode scanning error on
the instrument, the reload speed of the
carrier is not reduced to facilitate the
reading of the barcode again.
For information only. Scan the
barcode with the hand-held barcode
reader if needed.
y List of known issues for the cobas x 480 instrument
Roche Diagnostics
cobas® 4800 System · Software version 2.1 · cobas® 4800 System · Known Issues · Version 1.1
List of known issues for the cobas x 480 instrument 7
8
Tip eject to the tip
eject plate slot
If the system had a
hard abort, pipette
tips are ejected
onto the tip eject
plate slot.
If the run is aborted due to a hard abort
(e.g. a carrier was manually removed
from of the instrument during the
sample preparation process).
If a run is aborted by the system or a
user, before starting the next run,
check the tip eject plate slot for
pipette tips. Manually remove and
dispose of the pipette tips if needed.
# Issue Detail When can you encounter this problem Workaround
y List of known issues for the cobas x 480 instrument
Roche Diagnostics
cobas® 4800 System · Software version 2.1 · cobas® 4800 System · Known Issues · Version 1.1
8 List of known issues for the cobas z 480 analyzer
List of known issues for the cobas z 480
analyzer
# Issue Detail When can you encounter this problem Workaround
1
Incorrect
maintenance status
Maintenance status
is not refreshed.
After the connection to the
cobas z 480 analyzer is lost, the
maintenance status is not automatically
refreshed.
To get the current maintenance
status, wait until the connection to
the cobas z 480 analyzer is re-
established and the run is complete.
Then choose the Refresh button
under the Overview > System
> cobas z 480 tab.
2
Unrecoverable
software error
Unrecoverable
software error
when starting a
run.
If you start a run while the cobas z 480
analyzer is initializing, the cobas
®
4800
software generates an unrecoverable
error.
Before starting a run, wait for the
cobas z 480 analyzer to finish
initializing. If an unrecoverable error
occurs, shut down and restart the
cobas
®
4800 software.
3
Incorrect alarm
message
Incorrect
cobas z 480
analyzer
connection lost
message is
displayed in the
alarm area after a
refresh.
If you choose the Refresh button for
the cobas z 480 analyzer under the
Overview > System > cobas z 480
tab, a connection lost warning message
is displayed in the alarm area.
For information only. The warning
message does not affect the status of
the run.
4
Hardware error After a
cobas z 480
analyzer hardware
error, the
cobas
®
4800
software does not
automatically
restart.
After a cobas z 480 analyzer hardware
error.
If the cobas z 480 analyzer reports a
hardware error, restart the
cobas z 480 analyzer.
y List of known issues for the cobas z 480 analyzer
/