BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® HIV-1 (192T)

    MDR report key: 23113938 · Received September 22, 2025

    Report

    Report Number
    2243471-2025-03410
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    November 16, 2023
    Report Date
    September 22, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    MZF
    PMA / PMN Number
    BP150262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS 6800 ANALYZER (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT NO SYSTEMIC ISSUE WAS IDENTIFIED WITH THE KIT COBAS 58/68/8800 HIV 192T IVD ASSAY. THE OBSERVED DISCREPANCIES WERE ATTRIBUTED TO SAMPLE-SPECIFIC FACTORS. A REVIEW OF THE ALLEGED KIT LOT K00517, INCLUDING RELEASE AND STABILITY DATA, DID NOT INDICATE ANY PRODUCT-RELATED ISSUES. THE INSTRUMENT HAD UNDERGONE CALIBRATION AND VERIFICATION PROCESSES FOR HIV TESTING, AND THE LAST PREVENTIVE MAINTENANCE WAS PERFORMED ON 18-NOV-2023. POTENTIAL CONTRIBUTING FACTORS SUCH AS SAMPLE COLLECTION, HANDLING, STORAGE, AND PREPARATION WERE CONSIDERED BUT COULD NOT BE CONFIRMED DUE TO LIMITED INFORMATION. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE, AND NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED RESULT DISCREPANCIES DURING THE USE OF THE KIT COBAS 58/68/8800 HIV 192T IVD ASSAY ON THE COBAS 6800 PLATFORM. THE CUSTOMER TRANSITIONED THEIR HIV TESTING TO THE COBAS 6800 PLATFORM ON (B)(6) 2023. ON (B)(6) 2023, THE CUSTOMER REPORTED RECEIVING COMPLAINTS FROM PHYSICIANS REGARDING PATIENTS GENERATING LOW POSITIVE TITERS FOR HIV. THE CUSTOMER ALSO EXPRESSED CONCERNS ABOUT THE PRECISION OF THE ASSAY, NOTING THAT REPEAT RESULTS WERE UP TO 1 LOG OFF FROM THE ORIGINAL RUNS. FRESH PATIENT DRAWS WERE USED FOR INITIAL TESTING, WHILE REPEAT TESTS WERE PERFORMED ON SAMPLES STORED AT -8°C. THE FOLLOWING RESULTS WERE REPORTED FOR SPECIFIC SAMPLE IDS: SAMPLE ID (B)(6): 532.1 TITER CP/ML ON (B)(6) 2023, 1766 TITER CP/ML ON (B)(6) 2023, AND U02T FLAG ON (B)(6) 2023. SAMPLE ID (B)(6): 320 TITER CP/ML ON (B)(6) 2023, 208 TITER CP/ML ON (B)(6) 2023, AND NEG ON (B)(6) 2023. SAMPLE ID (B)(6): 334.7 TITER CP/ML ON (B)(6) 2023, 177.8 TITER CP/ML ON (B)(6) 2023, AND 42.0 TITER CP/ML ON (B)(6) 2023. SAMPLE ID (B)(6): 32.3 TITER CP/ML ON (B)(6) 2023, 210.9 TITER CP/ML ON (B)(6) 2023, AND NEG ON (B)(6) 2023. SAMPLE ID (B)(6): 79.3 TITER CP/ML ON (B)(6) 2023, 67.9 TITER CP/ML ON (B)(6) 2023, AND NEG ON (B)(6) 2023. SAMPLE ID (B)(6): 1351.7 TITER CP/ML ON (B)(6) 2023. REPEAT TESTING OF THIS SAMPLE (B)(6) ON (B)(6) 2023 YIELDED 36.7 TITER CP/ML AND 21.19 TITER CP/ML, RESPECTIVELY. THE CUSTOMER NOTED THAT THE PATIENTS IN QUESTION HAD PREVIOUSLY TESTED NEGATIVE FOR AN EXTENDED PERIOD AND WERE ON CERTAIN ANTIVIRAL MEDICATIONS. THE RESULTS WERE DISCREPANT BOTH BETWEEN THE COBAS 6800 PLATFORM AND THE ABBOTT M2000 SYSTEM, AS WELL AS BETWEEN INITIAL AND REPEAT TESTS ON THE COBAS 6800 PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510221 COBAS® HIV-1 (192T) HUMAN IMMUNODEFICIENCY VIRUS (HIV) VIRAL LOAD MONITORING TEST MZF ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K00517

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown