BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 23113814 · Received September 22, 2025

    Report

    Report Number
    2243471-2025-03398
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    March 15, 2024
    Report Date
    September 22, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 CONFIRMED THE REPORTED RESULT DISCREPANCY. THE COBAS MPX ASSAY GENERATED NON-REACTIVE RESULTS FOR HIV, HBV, AND HCV ON TWO SEPARATE SAMPLE IDS FROM THE SAME DONOR. SUBSEQUENT SEROLOGICAL TESTING ON THE ROCHE E801 ANALYZER, ABBOTT ALINITY S ASSAY, AND AN IMMUNOBLOT CONFIRMATORY TEST GENERATED REACTIVE RESULTS FOR HIV AND HCV. A REVIEW OF THE REAGENT KIT LOT K00715 DID NOT IDENTIFY ANY SYSTEMIC PRODUCT ISSUES. THE ROOT CAUSE OF THE NON-REACTIVE RESULTS COULD NOT BE DEFINITIVELY DETERMINED; HOWEVER, IT IS POSSIBLE THAT THE DISCREPANCY IS RELATED TO THE DONOR'S ONGOING ANTIVIRAL THERAPY. THE OBSERVED DISCREPANCY IS LIKELY SAMPLE-SPECIFIC. THE BLOOD BAG ASSOCIATED WITH THE DONOR SAMPLE WAS NOT RELEASED AND WAS DISCARDED. NO HARM WAS REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED A RESULT DISCREPANCY WITH THE KIT COBAS 58/68/8800 MPX 480T IVD ASSAY ON THE COBAS 6800 INSTRUMENT. ON (B)(6) 2024, THE SAME DONOR SAMPLE WAS TESTED UNDER TWO DIFFERENT SAMPLE IDS (B)(6) USING THE COBAS MPX ASSAY. BOTH TESTS GENERATED HIV NON-REACTIVE, HEPATITIS B VIRUS (HBV) NON-REACTIVE, AND HEPATITIS C VIRUS (HCV) NON-REACTIVE RESULTS. THE SAME DONOR SAMPLE WAS SUBSEQUENTLY TESTED USING SEROLOGICAL TESTING ON THE ROCHE E801 ANALYZER, WHICH GENERATED HIV AND HCV REACTIVE RESULTS. FURTHER TESTING WITH THE ABBOTT ALINITY S ASSAY AND AN IMMUNOBLOT CONFIRMATORY TEST ALSO GENERATED REACTIVE RESULTS FOR HIV AND HCV. THE BLOOD BAG ASSOCIATED WITH THE DONOR SAMPLE WAS NOT RELEASED AND WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026828 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K00715

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male