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

Catalog Number 07154003001

Device Problem Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that the cobas infinity software is not evaluating control results correctly.For example, a sodium control result transmitted from an integra analyzer was outside of range and it was expected the cobas infinity software would block the result and generate a status error due to the control rule set up in the infinity software.The control result was marked with a status of "ok" in the cobas infinity software and this result was validated.The same issue occurred with afp control results transmitted from another analyzer.There was no allegation of erroneous patient test results.The cobas infinity version is 3.02.04.1007.

Manufacturer Narrative

The investigation determined that the customer had configured the rule "status expiration control".It has been communicated to the customer that they are to disable or stop using the "status expiration control" rule until a service patch is available and implemented at the site.The communication provided to the customer applies to all versions of cobas infinity from version 3.00.00 onwards, including version 3.02.04.The customer installed cobas infinity software version 3.02.04 on (b)(6) 2020.The customer was provided this communication prior to the installation of this software, so the investigation determines the issue was caused by human error as they had already been warned of the existing risk.Medwatch field h7 has been updated.

• 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
• MDR Report Key: 11059697
• MDR Text Key: 244563906
• Report Number: 1823260-2020-03343
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

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
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1