BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 23169474 · Received September 29, 2025

    Report

    Report Number
    2243471-2025-03959
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 2, 2023
    Report Date
    September 29, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QHO
    PMA / PMN Number
    BL125576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS 6800 ANALYZER (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT NO PRODUCT ISSUE WITH THE KIT COBAS 58/68/8800 MPX 480T IVD REAGENTS OR ASSAY WAS OBSERVED. THE ANALYSIS OF RAW DATA FROM THREE RUNS INDICATED THAT THE INTERNAL QUALITY CONTROL (IQC) MATERIAL PROVIDED BY THE LOMBARDY REGION EXHIBITED VARIABILITY IN HIV TARGET DETECTION. THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED DUE TO LIMITED INFORMATION REGARDING THE PREPARATION AND PREANALYTICAL HANDLING OF THE EXTERNAL CONTROL MATERIAL. POTENTIAL CONTRIBUTING FACTORS INCLUDE THE INTRODUCTION OF AN INTERNAL INHIBITOR DURING PRODUCTION OR THE MATERIAL BEING NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY. POSITIVE HIV CURVES WERE NOTED TO BE LOW LEVEL BUT SHOWED AMPLIFICATION. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE, AND THE CUSTOMER WAS ADVISED TO ENSURE THAT IQC MATERIAL IS HANDLED AS CLOSELY AS POSSIBLE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT RESULTS WITH THE KIT COBAS 58/68/8800 MPX 480T IVD ON THE COBAS 6800 INSTRUMENT USING INTERNAL QUALITY CONTROL (IQC) MATERIAL PROVIDED BY THE (B)(6) REGION. THE IQC MATERIAL CONSISTS OF BIOLOGICAL SAMPLES WITH AN UNKNOWN VIRAL CONCENTRATION AND IS PREPARED BY FREEZING AND THAWING PRIOR TO EACH RUN. THE CUSTOMER¿S WORKFLOW INVOLVES RUNNING IQC MATERIAL DAILY, EXPECTING ALL THREE TARGETS (HIV, HBV, HCV) TO BE POSITIVE. THE ISSUE WAS OBSERVED IN RUN BATCH # 742, WHERE ONE OF THE HIV TARGETS WAS NONREACTIVE, WHILE THE INTERNAL CONTROL WAS POSITIVE. OTHER RUNS USING THE SAME IQC MATERIAL AND REAGENT LOT DID NOT EXHIBIT THIS ISSUE. THE RAW DATA PROVIDED FOR THREE RUNS INCLUDED THE FOLLOWING RESULTS FOR SAMPLE (B)(6): ON (B)(6) 2023 (RUN 736), THE SAMPLE WAS REACTIVE FOR HIV WITH A CYCLE THRESHOLD (CT) OF 37.74 AND AN INTERNAL CONTROL (IC) CT OF 36.69; ON (B)(6) 2023 (RUN 748), THE SAMPLE WAS REACTIVE FOR HIV WITH A CT OF 38.63 AND AN IC CT OF 36.99. POSITIVE HIV CURVES WERE NOTED TO BE LOW LEVEL BUT SHOWED AMPLIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772404 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG J23629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown