Roche cobas z 480 User manual

Brand: Roche

Model: cobas z 480

Type: User manual

Roche cobas z 480 is a fully automated system for molecular diagnostics that integrates sample preparation, amplification, and detection in a single instrument. It is designed to provide fast and accurate results for a wide range of molecular tests, including those for infectious diseases, oncology, and genetic disorders. The system is easy to use and can be operated by laboratory personnel with minimal training. With its high throughput and rapid turnaround time, the Roche cobas z 480 can help laboratories increase efficiency and improve patient care.

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.

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

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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

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.

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.

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.

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.

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.

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

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cobas® 4800 System List of known issues

EGFR Known Issues

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.

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.

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

Roche cobas z 480 User manual

Roche cobas z 480 User manual

Roche cobas z 480 User manual

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