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

Catalog Number	07154003001
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a software issue of missing result flags on three separate occasions with the cobas infinity core software.The customer provided an example of missing result flags for one patient: the customer performed patient testing on a cobas 8000 c 702 module serial number (b)(4).Reportedly the patient's initial results were urine total protein <0.07 g/l and urine creatinine <0.1 mmol/l with no alarm codes or flags.These results were released from the cobas infinity core software and reported outside the laboratory.Based on the initial total protein and creatinine results, allegedly the results were missing data flags.The total protein urine/csf reagent lot number was 570146 with an expiration date requested but not provided.The crep2 creatinine plus ver.2 reagent lot number was 591139 with an expiration date requested but not provided.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
During the investigation, the allegation could not be reproduced in a virtual environment.To continue with the investigation, the customer site was accessed.Information about the reported order could not be found in system trace or log files.The database was revised and it was observed that the tests of the order were not validated by the automatic validation process, but by user profiles.The tests that had alarms were correctly blocked from automatic validation, following the customer¿s validation criteria.There was no evidence in the system that supported that there had been a software issue in the cobas infinity that lead to the reported situation.With the available information, the investigation determined that there was no software issue or product problem.

• Brand Name: COBAS INFINITY CORE SOFTWARE
• Common Device Name: 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: 14630922
• Report Number: 1823260-2022-01663
• Device Sequence Number: 3739313
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 07154003001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown