BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 24963394 · Received April 23, 2026

    Report

    Report Number
    2243471-2026-01552
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 23, 2026
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER FOR THE COBAS 6800 ANALYZER IS (B)(6). DURING THE INVESTIGATION, THE AVAILABLE DATA WERE REVIEWED, AND THE RAW DATA SHOWED NO EVIDENCE OF AN INCORRECT HBV RESULT IN THE CORRESPONDING DETECTION CHANNEL. THE INTERNAL CONTROL (IC) OF THE SAMPLE EXHIBITS A ROBUST AMPLIFICATION CURVE, WHICH INDICATES THE ABSENCE OF POTENTIAL PCR INHIBITORS IN THE SAMPLE MATRIX. OVERALL, THE DATA POINTS TOWARDS THE POSSIBLE CONCLUSION THAT THE DONOR HAS A CHRONIC HBV INFECTION WHERE THE VIRUS IS PRESENT IN THE LIVER AND BLOOD, BUT REPLICATION IS AT A LOW LEVEL. CHRONIC CARRIERS CAN HAVE FLUCTUATING LEVELS OF HBV DNA, SOMETIMES RESULTING IN LOW VIRAL LOADS. SUCH VIRAL LOAD MAY BE TOO LOW TO DETECT. ADDITIONALLY, DIFFERENCES IN TEST SENSITIVITY AND METHODOLOGY BETWEEN NAT (TARGETING VIRAL DNA) AND SEROLOGY (DETECTING ANTIGENS OR ANTIBODIES) COULD CONTRIBUTE TO THE OBSERVED RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE HBV RESULTS WITH THE COBAS® MPX - 480T ASSAY FOR A DONOR SAMPLE TESTED ON A COBAS 6800 SYSTEM. IT WAS REPORTED THAT THE HBV RESULT WAS NON-REACTIVE, AND THE SEROLOGICAL TEST RESULT, USING ALINITY HBSAG, WAS 4,299.77 COI (REACTIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400510 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG N17729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male