BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQSCREEN MPX TEST V2

    MDR report key: 12627733 · Received October 13, 2021

    Report

    Report Number
    2243471-2021-03518
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 14, 2021
    Report Date
    March 4, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    UDI-DI
    00875197004045
    PMA / PMN Number
    BL125459
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH THE COURSE OF THE INVESTIGATION, A PRODUCT NON-CONFORMANCE WAS NOT IDENTIFIED WITH THE COMPLAINT KIT LOT. THE SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION. VIRAL LOAD TESTING ON 2 ALIQUOTS FROM THE SAMPLE WAS PERFORMED BY A THIRD-PARTY EXTERNAL LAB USING THE ABBOTT REALTIME VIRAL LOAD FOR HIV-1 TEST. NO VIRAL TARGET WAS IDENTIFIED. ADDITIONAL TESTING OF THE SAME ALIQUOTS WAS PERFORMED BY ROCHE USING THE COBAS HIV 1/2 QUALITATIVE ASSAY AND BOTH ALIQUOTS GENERATED NON-REACTIVE RESULTS FOR HIV-1 AND HIV-2. ROCHE MEDICAL AND SCIENTIFIC AFFAIRS NOTED THAT HIV-2 INFECTIONS IN DONORS ARE RARE, AND A PREVIOUS STUDY FROM THE AMERICAN RED CROSS REPORTED VERY LOW VIRAL LOADS IN THESE DONORS. THE POTENTIAL AND MOST LIKELY CAUSES FOR THIS PATTERN COULD BE A FALSE POSITIVE GEENIUS RESULT OR A TRUE HIV-2 INFECTION WITH VERY LOW VIRAL LOAD BELOW THE ROCHE TESTS' LIMIT OF DETECTIONS. BASED ON THE TOTALITY OF THE CASE, A PRODUCT PROBLEM WAS NOT IDENTIFIED. CORRECTED DEVICE CODE FROM A090803 FALSE NEGATIVE RESULT TO A090806 TEST RESULT - NON REPRODUCIBLE. (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER IN THE (B)(6) ALLEGED THE GENERATION OF (B)(6) RESULTS WITH THE COBAS TAQSCREEN MPX TEST, V2.0 FOR A PATIENT WHO GENERATED (B)(6) RESULTS. PATIENT WAS BEING SCREENING FOR (B)(6) AS A NEWLY ARRIVED EXPAT. NO DONATION WAS INVOLVED AND NO HARM WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522333 COBAS TAQSCREEN MPX TEST V2 HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H02619 00875197004045

    Patients

    Seq Age Sex Outcome Treatment
    1 Male