Roche cobas s 201 system User manual

Brand: Roche

Model: cobas s 201 system

Type: User manual

Roche cobas s 201 system is an automated molecular diagnostics system designed to provide fast and reliable results for infectious disease testing in clinical laboratories. With its advanced technology, the system offers:

High throughput: Processes up to 96 samples per run, allowing for efficient testing of large sample volumes.
Rapid turnaround time: Delivers results in as little as 3 hours, enabling timely diagnosis and treatment decisions.
Multiplex testing: Performs multiple tests simultaneously, increasing efficiency and reducing the need for multiple assays.
Comprehensive menu: Offers a wide range of assays for detecting various pathogens, including bacteria, viruses, and parasites.

High throughput: Processes up to 96 samples per run, allowing for efficient testing of large sample volumes.
Rapid turnaround time: Delivers results in as little as 3 hours, enabling timely diagnosis and treatment decisions.
Multiplex testing: Performs multiple tests simultaneously, increasing efficiency and reducing the need for multiple assays.
Comprehensive menu: Offers a wide range of assays for detecting various pathogens, including bacteria, viruses, and parasites.

cobas s 201 system

Configuration D SP1

Known Issues List for use with the

cobas® TaqScreen DPX Test

P/N: 06353983001-01

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cobas s 201 system

Table of Contents

Table of Contents ...........................................................................................................................2

Revision History .............................................................................................................................3

Preface .............................................................................................................................................4

1 Pooling and PDM Software Issues ...........................................................................................5

1.1 Pooling Wizard ............................................................................................................................... 5

1.1.1 Incorrect error message if a donor sample is loaded for a 2nd DPX PP1 .............................................. 5

1.2 Pooling Manager ............................................................................................................................. 5

1.2.1 Donor samples in a system rejected Secondary Pool are not listed for repeat testing ......................... 5

1.2.2 Donor IDs truncated in the Pooling Plate Report ..................................................................................... 5

1.3 Data Manager .................................................................................................................................. 5

1.3.1 Report marked reprint even if data has changed ....................................................................................... 5

1.3.2 Duplicate entries displayed in the Force Unresolved tab ........................................................................ 5

1.4 Report Manager .............................................................................................................................. 6

1.4.1 No report available for pools rejected by the laboratory administrator ................................................. 6

1.5 Backup and Archiving ..................................................................................................................... 6

1.5.1 Archiving procedures for Configuration D SP1 ........................................................................................ 6

1.6 Workflow ......................................................................................................................................... 6

1.6.1 Cannot abort a pooling run when a tip pickup error occurs ................................................................... 6

1.6.2 Aborting a pooling run after a control pipetting error locks the SK24 rack ......................................... 7

1.6.3 Plates with barcode reading errors are ignored ......................................................................................... 7

1.6.4 Donor samples incorrectly scheduled for SP12 from IP .......................................................................... 7

1.6.5 Donor samples can be retested in a Primary Pooling run for the same test .......................................... 7

1.6.6 IP remains pending for Batch Run if Pooling Manager disconnected from server ............................ 7

1.6.7 A full IP must be loaded before a partial IP for an (r) PP480 Batch Run ............................................... 8

2 Preparation, Amplification and Detection, and AMPLILINK Software Issues .....................8

2.1 AMPLILINK Software .................................................................................................................... 8

2.1.1 SK24 rack ID locked in AMPLILINK software ......................................................................................... 8

2.2 COBAS

AmpliPrep Instrument .................................................................................................... 8

2.2.1 False liquid level detection error blocks sample preparation ................................................................... 8

2.3 COBAS

TaqMan

Analyzer ............................................................................................................ 9

2.3.1 COBAS

TaqMan

Analyzer does not automatically start an incomplete SK24 rack ........................... 9

2.3.2 Abort Advanced function can affect COBAS

TaqMan

Analyzer operation ....................................... 9

Index .............................................................................................................................................10

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Revision History

Edition notice This is the Known Issues List for the cobas s 201 system Configuration D Service Pack 1 (SP1). For

reference purposes, please store this Known Issues List with your cobas s 201 system Configuration

D Operator's Manual.

If you should have any questions or concerns, please contact your local Roche representative.

Trademarks ROCHE, AMPLILINK, AMPLIPREP, TAQMAN, COBAS, and COBAS S are trademarks of Roche.

All other product names and their trademarks are the property of their respective owners.

Questions or comments regarding the contents of this manual can be directed to the address below

or to your Roche represntative.

Manual Version Revision Date

1.0 April 2011

Roche Molecular Systems, Inc.

Branchburg, NJ 08876

USA

Roche Molecular Systems, Inc.

4300 Hacienda Drive

Pleasanton, CA 94588

USA

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Preface

This document describes issues documented while testing the cobas s 201 system Configuration D

Service Pack 1 (SP1). A complete description of the issue, along with possible workarounds, are

provided.

Abbreviations The following abbreviations are used in this document. These abbreviations are also listed and

described in the cobas s 201 Configuration D Operator's Manual.

B19 Parvovirus B19

DPX Duplex. A duplex-target test that reports qualitative results

for HAV and quantitative results for B19

DPX test cobas

® TaqScreen DPX Test

HAV Hepatitis A Virus

IP Intermediate Plate

LLD Liquid level detection

LP Library Plate

PDM Pooling and data management

Pipettor Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

PPn Primary Pools of n

ResP1 Resolution Pooling

RMEC Roche-manufactured external control

rPPn Repeat Primary Pools of n

rResP1 Repeat Resolution Pooling

SPn Secondary Pools of n

UDEC User-defined external control

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1 Pooling and PDM Software Issues

1.1 Pooling Wizard

1.1.1 Incorrect error message if a donor sample is loaded for a 2nd DPX PP1

When a donor sample pooled in one DPX PP1 pooling run is loaded for a second DPX PP1 pooling

run, an error message is displayed, as expected. However, error 6010 (Donor xxx cannot be pooled

for MPX) is displayed instead of error 6001(Duplicate donor ID xxx detected at position xxx).

This is a display issue only. The donor sample is not accepted for the second DPX PP1 pooling run.

1.2 Pooling Manager

1.2.1 Donor samples in a system rejected Secondary Pool are not listed for repeat testing

In a Secondary Pooling run, donor samples in a pool that was rejected by the system due to

pipetting errors are not listed in the Details tab > Required Pooling tab and the Worklist tab >

Required Pooling tab. The donor samples are still available for retesting.

The operator should access the Details tab > Required Pooling tab for the original Primary Pooling

batch to see if there are any donor samples pending for testing, and retest them.

1.2.2 Donor IDs truncated in the Pooling Plate Report

The system accepts donor IDs with a barcode length from 2 to 20 characters. However, donor IDs

longer than 12 characters are truncated in the Pooling Plate Report.

This is only an issue in the Pooling Plate Report. The donor IDs are correctly stored in the

database.

1.3 Data Manager

1.3.1 Report marked reprint even if data has changed

A subsequent printing of a result report is labeled as a reprint, even if the report contains new

information (for example, donor samples were accepted after the first report was printed so the

Donor Status has changed). Reprint is intended to identify a duplicate copy of the original report.

The operator should use the date/time stamp on a report to identify the report containing the latest

information.

1.3.2 Duplicate entries displayed in the Force Unresolved tab

If a laboratory administrator queries for a donor sample in the Data Manager Worklist tab > Force

Unresolved tab, the donor sample record may be displayed multiple times. If the laboratory

administrator selects multiple entries for the same donor sample, and clicks Force Unresolve, a

message displays indicating the donor sample has already been accepted and an Oracle error (which

can be closed) is displayed. If the query is repeated the accepted donor sample is no longer listed.

The laboratory administrator should select only one entry if multiple records are displayed for the

same donor sample when using the force unresolved option. If multiple records for the same donor

sample are selected, then the donor sample with a Donor Status of Completed needs to be

manually accepted.

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1.4 Report Manager

1.4.1 No report available for pools rejected by the laboratory administrator

Report Manager does not contain a report to list pools rejected by the laboratory administrator in

the Pooling Manager Details tab > Pools View tab. The reason for rejection, entered in the

Comments section of the Electronic Signature Form, is not retrievable from PDM.

The operator can identify pools rejected by the laboratory administrator (Testing Status = User

Rejected) in the Pooling Manager Details tab > Pools View tab. The operator can capture the

reason for rejecting the pool by adding a comment for the pool in the Data Manager Details tab >

Pools Review tab, after the pool is rejected.

1.5 Backup and Archiving

1.5.1 Archiving procedures for Configuration D SP1

The laboratory administrator should note the following procedures when performing archiving for

Configuration D SP1: 1) Use a DVD-R or DVD+R; 2) formatting the DVD before archiving is no

longer required; 3) manual ejection of the archive disk is required immediately after archiving is

complete; 4) it is recommended to insert a new, blank DVD into the drive after the archive disk is

ejected; 5) confirm the PDM notification message concerning a pre-check error if displayed; 6) load

the archive DVD on a separate computer to get the data range from the archive directory, and label

the archive DVD with the data range.

1.6 Workflow

1.6.1 Cannot abort a pooling run when a tip pickup error occurs

When a tip pickup error is encountered before the controls are successfully pipetted, the Abort

button is disabled and the Cancel button is enabled on the displayed Tip Pick Up - Error dialog

box. This is contrary to the description in the cobas s 201 system Configuration D Operator's

Manual. If a tip is not present at the location but there are tips in the following locations, the

operator can click Next followed by Execute to proceed. If all tip racks are empty, and the operator

clicks Cancel to abort the pooling run, a Controls pipetting error dialog box is displayed and the

control carriers and SK24 rack are ejected. If the operator follows the onscreen instructions to

replace required consumables and clicks OK, the system resumes pipetting and encounters the

same tip pickup error. If the operator cancels the pooling run by clicking the Pooling Wizard

Abort button, the pooling run is successfully aborted, and the donor samples can be retested in the

next pooling run. However, the SK24 rack associated with the pipetting error is not released and

cannot be reused.

To avoid tip pickup errors, the operator should not manually remove any tips from the tip rack. In

the event that the tip pickup error occurs, the operator should not click the Cancel button. The

operator should click Next followed by Execute to proceed if tips are available in subsequent

locations. The operator should turn off the pipettor and restart the workstation and the pipettor if

all tip racks are empty. In the event that the anomaly occurs, the laboratory administrator should

contact Roche Service for a replacement SK24 rack or relabel the SK24 rack ID with new sticker

marked with a new barcode ID.

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1.6.2 Aborting a pooling run after a control pipetting error locks the SK24 rack

A Controls pipetting error dialog box is displayed if a control pipetting error occurs, as expected. If

the operator aborts the pooling run, instead of following the prompts in the dialog box, the run is

successfully aborted and the associated donor samples can be retested. However, the SK24 rack

associated with the failed control(s) is not released and cannot be reused.

To avoid the problem, the operator should follow the onscreen instructions. In the event that the

anomaly occurs, the laboratory administrator should contact Roche Service for a replacement SK24

rack or relabel the SK24 rack ID with new sticker marked with a new barcode ID.

1.6.3 Plates with barcode reading errors are ignored

If more than one Deep Well Plate is loaded on a plate carrier, and the barcode labels for all the

plates are unreadable, the carrier is ejected, and the operator is prompted to manually enter the

barcode for the plate in position one. The rest of the plates are ignored. In general, the operator is

only prompted to manually enter barcodes for an unreadable plate if a readable plate follows it.

The operator should verify that the correct number of plates is recognized by the pipettor. If there

are any plate barcode reading errors, a plate with a readable barcode should be loaded in the last

used position on the carrier.

1.6.4 Donor samples incorrectly scheduled for SP12 from IP

If an aspirate or a dispense error occurs during an SP12 pooling run from an Intermediate Plate, the

associated donor samples remain pending for SP12 from the Intermediate Plate, and the pooling

requests are not listed in the Required Pooling tab for the batch. The system should schedule the

donor samples for ResP1 from donor tubes, since the volume left in the IP well is not enough for a

second SP12 pooling run

The operator should change the pooling request for the affected donor samples from SP12 to ResP1

and then load the donor tubes for the Secondary Pooling run.

1.6.5 Donor samples can be retested in a Primary Pooling run for the same test

Donor samples tested in a one-step pooling run (PP1 or Short Run PP48) can be tested again in a

two-step pooling run (PP96 or PP480) for the same test. The first valid result is assigned to the

donor sample and transmitted to the LIS.

The operator should not retest donor samples in a Primary Pooling run for the same test.

1.6.6 IP remains pending for Batch Run if Pooling Manager disconnected from server

Proper error handling is performed during a PP480 Plate Run if a donor sample pipetting error

occurs, even if the Pooling Manager workstation is disconnected from the server. An Oracle error

displays at the end of the pooling run indicating the lost connection. Once the connection is

reestablished and the workstation rebooted, the IP is pending for a Batch Run but the donor sample

with the pipetting error is not scheduled for SP6. The IP remains pending for a Batch Run even after

it is successfully pipetted in a Batch Run. If the IP is loaded for another Batch Run, one Primary

Pool is prepared containing the 11 donor samples successfully pipetted into the well that would

have contained the donor sample with the pipetting error. These donor samples were already

included in a Primary Pool in the previous Batch Run. The IP is still pending for Batch Run. The

donor sample with the pipetting error is only scheduled for SP6 after the IP well is rejected.

To avoid this issue the operator should reject the IP well after the IP has been used in the first Batch

Run, and retest the affected donor samples in SP6.

For donors tested in more than one Primary Pool, the first valid result is assigned to the donor

sample and transmitted to the LIS.

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1.6.7 A full IP must be loaded before a partial IP for an (r) PP480 Batch Run

If multiple Intermediate Plates are loaded for an (r)PP480 Batch Run, to create two batches, and a

partial plate (with 40 wells) is loaded before a full plate (with 80 wells), samples are pipetted from

different plates into one pool, some wells on the last plate are not pipetted, and the last S-tube is left

empty. The Pooling Manager Audit Trail tab contains a message instructing the operator to

remove the empty S-tube.

To prevent this anomaly, the operator should load the full Intermediate Plates first. In the event that

the anomaly occurs, the operator should reject the batch and repeat the test.

2 Preparation, Amplification and Detection, and AMPLILINK

Software Issues

2.1 AMPLILINK Software

2.1.1 SK24 rack ID locked in AMPLILINK software

If any S-tubes on an SK24 rack are not processed by both the COBAS

® AmpliPrep Instrument and

the COBAS

® TaqMan® Analyzer, the SK24 rack ID remains locked in AMPLILINK software even

after results for the SK24 rack are accepted and transmitted. The SK24 rack is available for use in a

new pooling run, but the test orders sent by PDM software for the rack are not accepted by

AMPLILINK workstations.

The operator should manually purge the rack results from AMPLILINK software after the results

are accepted and transmitted.

2.2 COBAS® AmpliPrep Instrument

2.2.1 False liquid level detection error blocks sample preparation

A false liquid level detection error may occur for a reagent cassette (most commonly for the first

time use of a Lysis Buffer cassette). The error invalidates the S-tube that was scheduled to be

processed with this cassette. The entire batch is invalidated by PDM software if the S-tube contains

an RMEC. The error also blocks the remaining cassettes in the kit for up to 40 minutes. Samples

that were in process at the time of the error will complete sample preparation. No additional

samples will be processed unless a second reagent kit with the same lot number is loaded.

The operator should load an additional set of reagents with the same lot number to continue sample

preparation.

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2.3 COBAS® TaqMan® Analyzer

2.3.1 COBAS® Ta q M an ® Analyzer does not automatically start an incomplete SK24 rack

The run may not start automatically when an SK24 rack is loaded on the COBAS

® TaqMan®

Analyzer if the SK24 rack contains any samples flagged Preparation not done. If the operator does

not manually start the run before the stability time limit is exceeded, all samples in the rack are

flagged RUN_EXPIRY. Additionally, if the operator loads a successfully prepared SK24 rack, an

automatic start is triggered and the samples on both SK24 racks are flagged RUN_EXPIRY. The

issue is also observed when an operator loads an unexpired batch quickly after loading an expired

batch on the COBAS

® TaqMan® Analyzer.

The operator should verify that the run starts automatically once an SK24 rack is loaded. If the run

does not start automatically and there are no loading problems, the operator should click the Start

button in the AMPLILINK software Systems window to manually start the run. The operator

should also load a second rack on the COBAS

® TaqMan® Analyzer only after the COBAS® TaqMan®

Analyzer starts to pick up K-tubes from the first SK24 rack.

2.3.2 Abort Advanced function can affect COBAS

® Ta q M a n ®Analyzer operation

The Abort Advanced function can affect subsequent COBAS

® TaqMan® Analyzer operation on a

system that is enabled for automatic sample transfer via the docking station.

If an SK24 rack containing aborted orders is not unloaded and reloaded after the Abort Advanced

function is performed, all S-tubes (including those with aborted orders) are processed by the

COBAS

® AmpliPrep Instrument. When the processed K-tubes are transferred to the COBAS®

TaqMan

® Analyzer via the docking station:

o The COBAS

® TaqMan® Analyzer halts and has to be reinitialized if the aborted S-tube is not the

last tube on the SK24 rack.

o The corresponding K-tube is wasted, and the K-carrier is transferred into a thermal cycler

without K-tube re-handling, if the aborted S-tube is the last tube on the SK24 rack.

The operator should not perform the Abort Advanced function unless specifically instructed to do

so by Roche representatives.

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cobas s 201 system

Index

abbreviations, 4

Abort Advanced function can affect COBAS

® TaqMan®

Analyzer operation, 9

Abort button

– not enabled after tip pickup error, 6

AMPLILINK software

– locks SK24 rack, 8

barcode read error

– manual entry of plate barcodes not accepted, 7

COBAS® AmpliPrep Instrument

– false LLD error blocks sample preparation, 8

COBAS

® TaqMan® Analyzer

– does not start an SK24 rack, 9

contact addresses, 3

copyrights, 3

document information, 3

donor ID truncated in the Pooling Plate Report, 5

donor sample accepted for 2nd Primary Pooling run, 7

edition notice, 3

error message, incorrect

– donor sample loaded for 2nd DPX PP1, 5

Force Unresolved tab

– donor sample listed twice, 5

no report for user-rejected pools, 6

Operator’s Manual

–version, 3

Oracle error

– Force Unresolved option, 5

– Pooling Management workstation disconnected, 7

pipetting error

– donor samples assiged to SP12 instead of ResP1, 7

plate carrier

– manual barcode entry not accepted, 7

Pooling Manager

– improper pooling status if disconnected from server, 7

Pooling Plate Report

– donor IDs truncated, 5

PP480

– full IP must be loaded before partial IP, 8

– IP remains pending for Batch Run, 7

preface, 4

reject comments not retrievable, 6

report marked reprint even if data has changed, 5

reprint not used correctly, 5

Required Pooling tab

– missing donor samples, 5

revision history, 3

RUN_EXPIRY, 9

samples flagged RUN_EXPIRY, 9

SK24 rack ID locked, 6, 8

software, version, 3

SP12

– incorrectly scheduled, 7

trademarks, 3

Roche cobas s 201 system User manual

Brand: Roche

Model: cobas s 201 system

Type: User manual

High throughput: Processes up to 96 samples per run, allowing for efficient testing of large sample volumes.
Rapid turnaround time: Delivers results in as little as 3 hours, enabling timely diagnosis and treatment decisions.
Multiplex testing: Performs multiple tests simultaneously, increasing efficiency and reducing the need for multiple assays.
Comprehensive menu: Offers a wide range of assays for detecting various pathogens, including bacteria, viruses, and parasites.

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Roche cobas s 201 system User manual

Roche cobas s 201 system User manual

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