BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 96T

    MDR report key: 23116925 · Received September 22, 2025

    Report

    Report Number
    2243471-2025-03386
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    January 29, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS AMPLIPREP INSTRUMENT (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY PERFORMED WITHIN SPECIFICATIONS. THE REACTIVE HBV RESULT OBTAINED DURING RESOLUTION TESTING SHOWED A ROBUST, SIGMOIDAL GROWTH CURVE, CONSISTENT WITH TRUE TARGET AMPLIFICATION. THE POSITIVE CONTROL FOR HBV ALSO DEMONSTRATED ROBUST AND SIGMOIDAL PERFORMANCE, CONFIRMING THE ASSAY'S FUNCTIONALITY. THE NON-REACTIVE RESULT OBSERVED IN THE INITIAL POOL OF 6 (PP6) WAS ATTRIBUTED TO THE ASSAY'S LIMIT OF DETECTION (LOD). DILUTION OF THE SAMPLE IN THE POOL LIKELY PUSHED THE SAMPLE BELOW THE LOD, RESULTING IN A NON-REACTIVE OUTCOME. A SYSTEMIC PRODUCT ISSUE WAS NOT IDENTIFIED. THE DONATION WAS NOT USED, AND NO FURTHER HARM OR TREATMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED A RESULT DISCREPANCY WHEN USING THE KIT S201 T-SCRN MPX V2.0 96T US-IVD ASSAY ON THE COBAS AMPLIPREP INSTRUMENT. THE ALLEGATION INVOLVES A SAMPLE TESTED IN A POOL OF 6 (PP6) THAT WAS NON-REACTIVE FOR HEPATITIS B VIRUS (HBV). THE SAME SAMPLE WAS TESTED WITH A COMPETITOR ASSAY IN A POOL OF 8 AND WAS REACTIVE FOR HBV. SEROLOGY TESTING FOR HBV WAS PERFORMED TWICE AND WAS REACTIVE ON BOTH OCCASIONS. THE INITIAL PP6 WAS SUBSEQUENTLY TESTED IN RESOLUTION (RESP1), AND A REACTIVE RESULT FOR HBV WAS OBTAINED WITH A CYCLE THRESHOLD (CT) VALUE OF 36.5. THE REACTIVE HBV RESULT SHOWED A ROBUST, SIGMOIDAL GROWTH CURVE INDICATIVE OF TRUE TARGET AMPLIFICATION. THE DONATION WAS PLASMA, AND THE BLOOD WAS NOT USED. THE RESULT WAS NOT REPORTED TO LOCAL AUTHORITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202032 COBAS® MPX - 96T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K20768

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male