BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 96T

    MDR report key: 23136839 · Received September 24, 2025

    Report

    Report Number
    2243471-2025-03623
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    March 18, 2024
    Report Date
    September 24, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS 6800 SYSTEM (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE COBAS MPX ASSAY AND THE COBAS 6800 SYSTEM PERFORMED WITHIN SPECIFICATIONS. NO PRODUCT-RELATED ISSUES WERE IDENTIFIED WITH THE COBAS MPX ASSAY LOT J26034 OR THE COBAS 6800 SYSTEM. A REVIEW OF THE RAW DATA AND QUALITY CONTROL INFORMATION CONFIRMED THAT ALL CONTROLS WERE VALID, AND NO HARDWARE-RELATED ISSUES WERE OBSERVED. THE DISCREPANCY IN RESULTS IS LIKELY ATTRIBUTED TO THE VERY LOW VIRAL LOAD INDICATED BY THE INITIAL CYCLE THRESHOLD (CT) VALUE OF APPROXIMATELY 43, WHICH IS NEAR THE ASSAY'S DETECTION THRESHOLD. OTHER POTENTIAL CONTRIBUTING FACTORS INCLUDE SAMPLE DEGRADATION, TESTING VARIABILITY, OR NON-SPECIFIC AMPLIFICATION, WHICH CAN OCCUR AT A VERY LOW RATE DUE TO THE NATURE OF PCR. CONTAMINATION OF THE SAMPLE TUBE WAS DEEMED UNLIKELY, AS THE HCV VIRAL LOAD TEST DID NOT DETECT ANY HCV RNA FROM THE SAME TUBE AS THE INITIAL REACTIVE TEST. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE, AND NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR A SAMPLE TESTED WITH THE KIT COBAS 6800/8800 MPX 96T CE-IVD ASSAY ON THE COBAS 6800 SYSTEM. ON (B)(6)2024, THE SAMPLE WAS INITIALLY TESTED USING THE COBAS MPX ASSAY (LOT J26034) AND GENERATED A REACTIVE RESULT WITH A CYCLE THRESHOLD (CT) VALUE OF 43.26. THE SAMPLE WAS THEN RETESTED ON THE SAME DAY USING A SECOND PLASMA TUBE WITH THE COBAS MPX ASSAY (LOT J24218), WHICH GENERATED A NON-REACTIVE RESULT. ADDITIONALLY, THE SAMPLE FROM THE FIRST PLASMA TUBE WAS TESTED USING THE COBAS HCV VIRAL LOAD ASSAY (LOT K04951) ON THE SAME DAY, WHICH REPORTED "TARGET NOT DETECTED." THE PATIENT TESTED NEGATIVE FOR HEPATITIS C VIRUS (HCV) SEROLOGY, ALTHOUGH THE TESTING PLATFORM USED FOR SEROLOGY WAS NOT SPECIFIED. BLOOD WAS COLLECTED IN TWO PLASMA TUBES, AND ALL TESTS WERE PERFORMED ON THE SAME DAY WITHOUT SUBJECTING THE SAMPLE TO FREEZE-THAW CYCLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493145 COBAS® MPX - 96T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG J26034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown