BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 23095585 · Received September 19, 2025

    Report

    Report Number
    2243471-2025-03176
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    February 28, 2024
    Report Date
    September 19, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS WAS PERFORMED ON A COBAS 5800 INSTRUMENT (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE KIT COBAS 58/68/8800 MPX 480T IVD ASSAY PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF THE PROVIDED DATA INDICATED THAT THE SAMPLE IN QUESTION EXHIBITED A LOW VIRAL LOAD, WITH RESULTS NEAR THE LIMIT OF DETECTION OF THE ASSAY. THIS IS CONSISTENT WITH THE OBSERVED WAVERING RESULTS BETWEEN REACTIVE AND NON-REACTIVE OUTCOMES. NO ABNORMALITIES WERE IDENTIFIED IN THE SYSTEM OR REAGENT PERFORMANCE, AND NO SYSTEMIC PRODUCT ISSUE WAS DETECTED FOR REAGENT KIT LOT K00715. THE INVESTIGATION ALSO NOTED THAT DEVIATIONS FROM OPTIMAL WORKFLOW, SUCH AS POTENTIAL CROSS-CONTAMINATION, COULD CONTRIBUTE TO UNEXPECTED REACTIVE RESULTS IN A CLINICAL CONTEXT. THE ROOT CAUSE WAS ATTRIBUTED TO A SAMPLE-SPECIFIC ISSUE RELATED TO LOW VIRAL CONCENTRATION. THE RESULTS HAVE NOT BEEN RELEASED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS FOR A SINGLE INDIVIDUAL DONOR TESTING (IDT) SAMPLE USING THE KIT COBAS 58/68/8800 MPX 480T IVD ON THE COBAS 5800 INSTRUMENT. ON (B)(6) 2024, THE SAMPLE (ID: (B)(6)) GENERATED A REACTIVE RESULT FOR THE HIV TARGET WITH A CYCLE THRESHOLD (CT) VALUE OF 35.96. THE GROWTH CURVE SHOWED A SIGMOIDAL CURVE WITH LATE AMPLIFICATION, INDICATING A LOW VIRAL LOAD. ON (B)(6) 2024, THE SAME SAMPLE WAS RETESTED UNDER TWO DIFFERENT IDS (B)(6) AND BOTH GENERATED NON-REACTIVE RESULTS FOR THE HIV TARGET. THE RESULTS HAVE NOT BEEN RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721144 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K00715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown