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	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation confirmed there was a software issue with the cobas infinity software.When the system tries to add a result status to the test by editing a table (tresultalarms), if the table is locked, the system fails to add the result status.
Event or Problem Description
The initial reporter stated there was an issue with the cobas infinity software.A sample test result sent by an instrument to the cobas infinity software with a data flag indicating the value was over the technical limit of the assay.The value was expected to be flagged with the status "blocked by instrument alarm" (bia), but the cobas infinity software did not add this flag to the result.The issue could potentially allow an incorrect patient result to be validated and reported outside of the laboratory.
Additional Manufacturer Narrative
Fda request: this report indicates that erroneous results could be reported due to a confirmed software error.Do you have plans to correct the software error, if so please provide a summary.Manufacturer response: mdr 1823260-2023-01865 was submitted as an initial report as the investigation was still on-going.The investigation is now complete.For this case, according to the customer configuration, when cobas® infinity receives a result with an instrument alarm, the validation criterion used "hold with instrument alarms" prevents the result from being validated, and a result status bia "blocked by instrument alarm" is added to the result.In this case, the result was appropriately held and not automatically validated by cobas® infinity, however the result status bia was not added to the result.The customer has different appearances configured depending on the result status.In this scenario, the expected result was that the bia result status should have been added to the result, thus turning the background of the result from an orange background to a blue background.In this specific scenario, as the bia result status was not added, the orange background did not change to blue in the validation screen, however, the correct result and instrument flags were present.There was no change to the actual result sent from the instrument to cobas® infinity.The issue described has no impact on the accuracy of test results or in their correct release to the prescribing physician and there are no clinical consequences for the patients under examination.The issue has been added to our backlog list and will be addressed in a future release.Fda request: also, is this related to your april recall reviewed by cber, 1823260-04/11/2023-001-c? manufacturer response: the software error associated with mdr 1823260-2023-01865, is not related to the recall reviewed by cber, 1823260-04/11/2023-001-c.The component, evaluation result, and evaluation conclusion codes have been updated.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17072969
• Report Number: 1823260-2023-01865
• Device Sequence Number: 17836597
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 07/11/2023

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: 05/09/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/11/2023
• 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