BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 96T

    MDR report key: 23099610 · Received September 19, 2025

    Report

    Report Number
    2243471-2025-03213
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 23, 2020
    Report Date
    September 19, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS 6800 ANALYZER (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE KIT COBAS 6800/8800 MPX 96T CE-IVD ASSAY PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF THE CUSTOMER'S DATA INDICATED THAT THE HBV CYCLE THRESHOLD (CT) VALUE OF 38.78 WAS CONSIDERED A LATE CT VALUE, SUGGESTING A TITER BELOW THE 0.5X LIMIT OF DETECTION (LOD) OF THE ASSAY. THIS PHENOMENON CAN RESULT IN RESULTS WAVERING BETWEEN REACTIVE AND NON-REACTIVE UPON RETESTING. NO PRODUCT-RELATED ISSUES, TRENDS, OR INTERNAL NON-CONFORMANCES WERE IDENTIFIED DURING THE INVESTIGATION. THE ROOT CAUSE WAS ATTRIBUTED TO THE SAMPLE'S TITER BEING NEAR THE ASSAY'S LOD, WHICH IS CONSISTENT WITH THE OBSERVED RESULTS. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WERE GENERATED USING THE KIT COBAS 6800/8800 MPX 96T CE-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. ON (B)(6) 2020, SAMPLE ID (B)(6) WAS TESTED AND GENERATED NEGATIVE RESULTS FOR ALL THREE TARGETS: HEPATITIS B VIRUS (HBV), HEPATITIS C VIRUS (HCV), AND HUMAN IMMUNODEFICIENCY VIRUS (HIV). THE BLOOD WAS NOT RELEASED, AND NO HARM WAS ALLEGED. ON (B)(6) 2020, THE SAME SAMPLE WAS MISTAKENLY REPEATED AS A SECOND DRAW FROM THE ORIGINAL ALIQUOT AND GENERATED A POSITIVE HBV TARGET RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 38.78 ON A SECOND COBAS 6800/8800 INSTRUMENT. SEROLOGY TESTING FOR THE SAMPLE WAS POSITIVE FOR ANTI-HBC, BUT NEGATIVE FOR BOTH HBSAG AND HBSAB. THE RESULTS WERE NOT REPORTED TO THE DONOR, AND THE BLOOD WAS NOT RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397168 COBAS® MPX - 96T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG F21681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown