MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY CORE SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 07154003001

Device Problem Operating System Version or Upgrade Problem (2997)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).Medwatch field facility name - the full facility name was provided as (b)(6).

Event Description

The customer stated that the cobas infinity system was upgraded from software version 1.2.22 to software version 2.0.11.0051 on (b)(6) 2017.After doing this, westgard rules could not be applied to control results from cobas 8000 analyzers.Westgard rules could be applied normally to control results from cobas integra 800 analyzers and cobas e 411 immunoassay analyzers.No adverse events were alleged.Some westgard rules for cobas 8000 analyzers were re-created on the cobas infinity system, but the westgard rules still were not applied to control results from cobas 8000 analyzers.Changes were made to the qc table in the new software version.Not all qc rules are being updated when the cobas infinity software is upgraded to the new version, so obsolete qc rules are being executed after the upgrade.The investigation found that, if only some qc rules were recreated, the new rules would not be applied.All rules must be recreated in order for the new rules to be applied.The investigation found that the issue could potentially affect patient results.Further information on possible impact to patients has been requested.The allegation could be reproduced and was verified as a software issue.

Manufacturer Narrative

Patient results could be affected since out of range control values may potentially be validated/released manually or automatically without the customer being aware of an issue with the controls.Incorrect patient sample results could potentially be released if out of range control values are believed to be valid.This could not yet be confirmed for the event.Analysis of the allegation ongoing.

Manufacturer Narrative

The observed behaviour is due to a change made in the quality control rules table in 2.0 versions and above.The expected values of a table column for some communication server instrument drivers is a different one, but those values are not updated during the upgrade, so the obsolete rules are executed after the upgrade.The investigation found that, if only some quality control rules were recreated, the new rules would not be applied.All rules must be recreated in order for the new rules to be applied.If a single patient test result was questioned based on the clinical picture of the patient and other clinical findings, it is likely to be carefully assessed, repeated, and verified by additional tests.Other than short delays in making a definitive diagnosis, no relevant health consequences are likely to occur.

Manufacturer Narrative

A software patch was supplied to the customer to resolve the issue.The software patch included changes in the handling method of the quality control rules so that both old and new control rules could be applied.On (b)(4) 2017, the customer stated that a westgard rule was not applied to total protein quality control results from the cobas 8000 analyzer.A new control rule was created on the cobas infinity system and new control values were evaluated.The issue still persisted.Investigations determined that there was an issue with the software patch as it included a bug in the source code that caused new control rules not to be handled correctly and therefore these rules were not executed.The issue could be reproduced during investigations.Based on further testing performed in the investigation, the issue was no longer reproduced after the software patch was de-installed.As a workaround to the customer's issue, the customer is instructed to de-install the software patch, delete the rules created before the software version 2.0 upgrade, and then re-create these.

• Brand Name: COBAS INFINITY CORE SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6540124
• MDR Text Key: 74313355
• Report Number: 1823260-2017-00939
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07154003001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/04/2017
• Supplement Dates FDA Received: 05/03/2017; 05/17/2017; 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1