BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 23156050 · Received September 26, 2025

    Report

    Report Number
    2243471-2025-03783
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    April 1, 2024
    Report Date
    September 26, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS 8800 ANALYZER (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE KIT COBAS 58/68/8800 MPX 480T IVD ASSAY WAS PERFORMING WITHIN SPECIFICATIONS. A REVIEW OF THE DATA INDICATED THAT THE REACTIVE HBV RESULT SHOWED A CYCLE THRESHOLD (CT) VALUE OF 37.24 WITH A SLIGHTLY ROBUST, SIGMOIDAL GROWTH CURVE, CONSISTENT WITH TRUE TARGET AMPLIFICATION. THE POSITIVE CONTROL FOR HBV WAS ALSO ROBUST AND SIGMOIDAL, CONFIRMING PROPER ASSAY FUNCTIONALITY. THE NON-REACTIVE RESULT OBTAINED DURING RESOLUTION TESTING WAS ATTRIBUTED TO THE ASSAY'S LIMIT OF DETECTION (LOD). TESTING IN A POOL OF SIX (PP6) DILUTED THE SAMPLE 1:6, POTENTIALLY PUSHING IT BELOW THE LOD, WHICH CAN RESULT IN NON-REACTIVE OUTCOMES. A SYSTEMIC PRODUCT ISSUE WAS NOT IDENTIFIED, AND THE INVESTIGATION CONCLUDED THAT THE OBSERVED RESULTS WERE CONSISTENT WITH THE EXPECTED PERFORMANCE OF THE ASSAY.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED A RESULT DISCREPANCY WHEN USING THE KIT COBAS 58/68/8800 MPX 480T IVD ASSAY ON THE COBAS 8800 INSTRUMENT. THE ALLEGATION INVOLVED A SAMPLE TESTED IN A POOL OF 6 (PP6) THAT GENERATED A NON-REACTIVE RESULT FOR HEPATITIS B VIRUS (HBV) ON (B)(6) 2024. SEROLOGY TESTING ON A COMPETITOR'S ASSAY WAS REACTIVE FOR HBV (HBCORE). THE INITIAL PP6 SAMPLE WAS SUBSEQUENTLY TESTED IN RESOLUTION (RESP1) ON (B)(6) 2024, AND A NON-REACTIVE RESULT FOR HBV WAS OBTAINED. THE REACTIVE HBV RESULT FROM THE INITIAL TESTING SHOWED A CYCLE THRESHOLD (CT) VALUE OF 37.24 AND A SLIGHTLY ROBUST, SIGMOIDAL GROWTH CURVE. THE DONATION WAS NOT USED, AND THE RESULTS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123635 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K16865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown