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

Catalog Number 07154003001

Device Problems Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

During correlations, the analyzer was changed to report in ug/ml.However, the units were not changed in the cobas infinity.It was discovered that a conversion factor was missing in the cobas infinity software or customer host lis which was reporting in umol/l.A conversion factor was installed and all incorrect results were amended and issued to clinicians.This event occurred in (b)(6).

Event Description

The initial reporter received incorrect results for carb3 carbamazepine and valp2 valproic acid from a cobas 8000 system due to an issue with the cobas infinity.It was discovered that carbamazepine and valproic acid results were being reported from the analyzer as ug/ml.The cobas infinity was set up with the units of umol/l.As a result, the final results were reported in the customer's lis and to clinicians as umol/l even though the results were actually ug/ml.This was discovered when a clinician questioned reported results on a patient.A total of 5 carbamazepine results and 48 valproic acid results were discrepant.

Manufacturer Narrative

The investigation determined the cobas infinity was working as designed.It was concluded that the tests were not correctly configured in the software due to human error, causing it to send test results with incorrect units to the lis.

• 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: 11193638
• MDR Text Key: 227583123
• Report Number: 1823260-2021-00200
• 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
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

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
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1