BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® HIV-1 (192T)

    MDR report key: 19654832 · Received July 2, 2024

    Report

    Report Number
    2243471-2024-01914
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    March 22, 2024
    Report Date
    July 9, 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
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. BECAUSE THE RESULTS WERE REPRODUCIBLE AS TARGET NOT DETECTED (TND) WITH THE ROCHE ASSAY AND THE ABBOTT COMPETITOR TEST CONFIRMED A TITER OF 30000CP/ML W/ SEROLOGY RESULTS POSITIVE, THE ISSUE WAS FOUND TO BE CONSISTENT WITH A MUTATION WHICH FALLS UNDER THE PRIMER AND PROBES OF THE ROCHE ASSAY. PER PRODUCT LABELING FOR THE ASSAY: THOUGH RARE, MUTATIONS WITHIN THE HIGHLY CONSERVED REGIONS OF A VIRAL GENOME COVERED BY COBAS® HIV-1 MAY AFFECT PRIMERS AND/OR PROBE BINDING RESULTING IN THE UNDER-QUANTITATION OF VIRUS OR FAILURE TO DETECT THE PRESENCE OF VIRUS.

    Additional Manufacturer Narrative · 0

    THE COBAS 6800 SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE NEGATIVE COBAS® HIV-1 (192T) RESULTS FROM THE COBAS 6800 ANALYZER FOR APPROXIMATELY 14 PATIENTS. SPECIFIC DATA WAS PROVIDED FOR ONE PATIENT. ON (B)(6) 2024, THE HIV RESULT ON THE COBAS 6800 (PLASMA SAMPLE) WAS TARGET NOT DETECTED (TND) WHILE THE HIV ANTIGEN RESULT FROM AN IMMUNOLOGY ASSAY (SERUM SAMPLE) WAS POSITIVE. FOR CONFIRMATION, THE PATIENT'S SERUM SAMPLE WAS SENT FOR TESTING AT ANOTHER LAB VIA WESTERN BLOT. THE RESULT WAS CONFIRMED TO BE POSITIVE WITH A HIGH CONCENTRATION OF ANTIGEN AND ANTIBODY. THE ABBOTT HIV QPCR RESULT WAS APPROXIMATELY 30000 COPIES. ON (B)(6) 2024, THE PLASMA SAMPLE WAS REPEATED USING COBAS® HIV-1 (192T) ON THE C6800 AND THE RESULT WAS TARGET NOT DETECTED (TND).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756457 COBAS® HIV-1 (192T) HUMAN IMMUNODEFICIENCY VIRUS (HIV) VIRAL LOAD MONITORING TEST QUM ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG J33290 00875197006407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female