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

Catalog Number 07154003001

Device Problem Application Program Version or Upgrade Problem (2881)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

Event Type  malfunction  

Event Description

The initial reporter states there is an issue with their cobas infinity software.A rule was created in the cobas infinity software to block test results marked with a flag indicating that the sample is hemolytic.The reporter states that the rule is triggered sometimes and sometimes not.When the rule is not triggered, the software will not block the result and the result is sent to the customer's laboratory information system.

Manufacturer Narrative

The investigation determined there is an issue with low performance of the rule engine of the software.There is a delay in applying a rule to a result.This issue is causing the customer to think that the rule execution has failed, and therefore they have to manually perform the action that was supposed to be performed by this rule.If the result is not manually modified, the rule will eventually be executed and correctly modify the result.

• 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: 12408966
• MDR Text Key: 270665259
• Report Number: 1823260-2021-02552
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• 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
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

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: 08/05/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1