BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 192T

    MDR report key: 23136157 · Received September 24, 2025

    Report

    Report Number
    2243471-2025-03604
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 26, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS 6800 ANALYZER (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE KIT COBAS 58/68/8800 MPX 192T CE-IVD ASSAY PERFORMED WITHIN SPECIFICATIONS. THE OBSERVED DISCREPANCIES, INCLUDING THE VARIATION IN RESULTS FOR THE 1X LIMIT OF DETECTION (LOD) HBV DNA CONTROL, WERE ATTRIBUTED TO SAMPLE-SPECIFIC FACTORS. NO SYSTEMIC ISSUE WAS IDENTIFIED, AND A REVIEW OF BATCH DATA DID NOT REVEAL ANY TRENDS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED QUESTIONED RESULTS GENERATED DURING THE USE OF THE KIT COBAS 58/68/8800 MPX 192T CE-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. ON (B)(6) 2024, THE CUSTOMER OBSERVED A POSITIVE CT (CYCLE THRESHOLD) VALUE OF 41.19 FOR THE HBV CONTROL. ON (B)(6) 2024, AN EXTERNAL 1X LIMIT OF DETECTION (LOD) HBV DNA CONTROL TESTED NEGATIVE. THE CUSTOMER SUBSEQUENTLY RETESTED THE SAME 1X LOD PANEL AND GENERATED A POSITIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643066 COBAS® MPX - 192T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K23680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown