BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 25092575 · Received May 6, 2026

    Report

    Report Number
    2243471-2026-01753
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    February 25, 2026
    Report Date
    May 6, 2026
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL 125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER IS (B)(6). THE REVIEW OF THE PCR SIGNALS OF THE IDT RESULTS VERIFIED ACCURATE RESULT CALLING. THERE IS NO INDICATION OF A MISCALLING BASED ON THE GENERATED PCR SIGNALS. THE DATA ANALYSIS REVEALED NO ANOMALIES IN THE ALGORITHM THAT COULD LEAD TO ERRONEOUS RESULTS. AN OVERALL REVIEW OF THE SYSTEM PERFORMANCE OF COBAS® 6800 INSTRUMENTS (B)(6), AS WELL AS THE COBAS® MPX REAGENT LOT N01895, DID NOT INDICATE ANY POTENTIAL CONTRIBUTING FACTORS. BASED ON THIS EVALUATION, THESE FACTORS WERE EXCLUDED AS POTENTIAL ROOT CAUSES OF THE UNEXPECTED RESULTS. THE DISCREPANCY BETWEEN THE NON-REACTIVE POOL OF 6 (PP6) RESULT AND THE REACTIVE INDIVIDUAL DONATION TESTING (IDT) RESULT CAN BE PRIMARILY EXPLAINED BY THE DILUTION EFFECT OF SAMPLE POOLING COMBINED WITH AN EXTREMELY LOW VIRAL LOAD CHARACTERISTIC OF CHRONIC HBV INFECTION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE HBV RESULTS WITH COBAS® MPX - 480T FOR DONOR SAMPLES TESTED ON THE COBAS 6800 ANALYZER. A PRIMARY POOL OF 6 (PP6) WAS TESTED AND THE RESULT WAS NON-REACTIVE. ON (B)(6) 2026, AN INDIVIDUAL DONOR FROM THE POOL WAS TESTED AND THE RESULT WAS REACTIVE FOR HBV. THE SEROLOGY RESULTS WERE REACTIVE FOR HBSAG AND ANTI-HBC USING THE ALINITY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178110 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG N01895

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown