MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY LAB CORE LICENSE 3.X; CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE

Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	Viral Infection (2248)
Date of Event	03/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation has confirmed the customer's allegation.The investigation is ongoing.
Event or Problem Description
There was an allegation of a positive hiv result being interpreted as negative on the cobas infinity core software for 1 patient sample.It was alleged that on (b)(6) 2022, a patient was tested for hiv.The result was allegedly reported in the infinity software as negative and this result was reported outside of the laboratory.After the patient¿s partner was determined to be hiv positive, the patient underwent further testing.In feb 2023, the patient was tested at another laboratory and found to be hiv positive.The original reporting laboratory was recently informed of the new patient result and investigated the discrepancy.
Additional Manufacturer Narrative
The reported allegation was verified as a software issue in cobas infinity.It was found that the software was not handling the repetition number of embedded results properly after the repetition was requested by a user that had missing permissions due to a software issue.The issues of the software not correctly assigning the permissions to embedded tests from a cobas e-flow and not correctly handling repetitions have been identified and are currently being addressed.The issue was identified as only occurring from 24-mar to 30-mar-2022.No further occurrences have been identified.The current workaround is to remove the permissions for the whole test group, including the e-flow test and assigning the tests one by one.Additionally, it is recommended to change the "automatic result for repetitions" parameter to the default value "no result" for all configured cobas e-flow tests.The issue was solved by editing the main test and creating a new version on 10-apr-2022.

• Brand Name: COBAS INFINITY LAB CORE LICENSE 3.X
• 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 INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; na; rotkreuz 6343 ; SZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16548129
• Report Number: 1823260-2023-00815
• Device Sequence Number: 12375218
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 04/21/2023; 04/20/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/15/2023; 05/25/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 92085
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown