BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® HIV-1 (192T)

    MDR report key: 18870589 · Received March 8, 2024

    Report

    Report Number
    2243471-2024-00718
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    November 1, 2023
    Report Date
    May 16, 2024
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QUM
    UDI-DI
    00875197006407
    PMA / PMN Number
    BP150262/56
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED ONE COBAS 6800 SERIAL NUMBER AS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    REVIEW OF THE PROVIDED DATA DID NOT REVEAL ANY ISSUES. AN INTERNAL INVESTIGATION INTO THIS ALLEGATION WAS PERFORMED AND THE CONCLUSION WAS THAT THE REAGENTS HAVE HAD NO DEVIATIONS DURING MANUFACTURING AND MEET THE SPECIFICATIONS SET FOR RELEASE. NO TREND WAS IDENTIFIED. NO PRODUCT PROBLEM WAS IDENTIFIED. THE ISSUE IS LIKELY RELATED TO PRE-ANALYTICAL HANDLING. LOT-TO-LOT VARIABILITY CAN ALSO BE A CONTRIBUTING FACTOR.

    Description of Event or Problem · 0

    A CUSTOMER ALLEGED FALSE POSITIVE HIV-1 RESULTS FROM SEVERAL COBAS 6800 ANALYZERS AND 8800 ANALYZERS AT THE CUSTOMER SITE. THE PATIENTS ARE TESTED FOR MONITORING PURPOSES AND ARE REGULARLY NEGATIVE. ALLEGEDLY, MANY OF THESE PATIENTS RETURN FOR TESTING FOLLOWING A PREVIOUS POSITIVE RESULT AND LATER TEST NEGATIVE AGAIN. EACH TEST RESULT WAS OBTAINED FROM A FRESH BLOOD DRAW WITH NO CHANGES IN TREATMENT. THE PATIENT SAMPLE IDS HAVE BEEN REQUESTED BUT HAVE NOT BEEN PROVIDED, THEREFORE THE SPECIFIC PATIENT DATA FOR EACH PATIENT CAN NOT BE DETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060792 COBAS® HIV-1 (192T) HUMAN IMMUNODEFICIENCY VIRUS (HIV) VIRAL LOAD MONITORING TEST QUM ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K00224, K00517 00875197006407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown