BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 23073477 · Received September 17, 2025

    Report

    Report Number
    2243471-2025-02984
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    December 6, 2019
    Report Date
    September 17, 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 THE ALLEGED NON-REACTIVE RESULTS WERE CONSISTENT WITH THE LIMITATIONS OF THE ASSAY. THE HBV CT VALUES OBSERVED IN THE INITIAL REACTIVE RESULTS WERE BEYOND THE 0.5X LOD PANEL CT VALUES ESTABLISHED DURING QC RELEASE FOR THE REAGENT LOT IN QUESTION, INDICATING A VIRAL LOAD BELOW THE ASSAY'S LIMIT OF DETECTION. THIS CAN RESULT IN RESULTS FLUCTUATING BETWEEN REACTIVE AND NON-REACTIVE. ADDITIONALLY, THE INVESTIGATION IDENTIFIED THAT THE INVALID RESULTS WERE LIKELY CAUSED BY SUBOPTIMAL PRE-ANALYTICAL SAMPLE HANDLING AT THE CUSTOMER SITE. PRACTICES SUCH AS FREEZING PRIMARY TUBES WITH GEL, PROLONGED REFRIGERATION OF PRIMARY TUBES, OR RE-SUSPENSION VIA PIPETTE WERE NOTED. THESE HANDLING METHODS CAN DEGRADE SAMPLE INTEGRITY, LEADING TO INVALID RESULTS. NO FURTHER INVESTIGATION WAS CONDUCTED AS THE OBSERVED RESULTS WERE ATTRIBUTED TO ASSAY LIMITATIONS AND SAMPLE HANDLING PRACTICES. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED INVALID RESULTS AND FALSE NON-REACTIVE RESULTS WITH THE KIT COBAS 6800/8800 MPX 480T CE-IVD ASSAY ON THE COBAS 6800 INSTRUMENT. THE CUSTOMER REPORTED TWO SAMPLES WITH HISTORICAL HBV REACTIVE RESULTS THAT WERE RETESTED IN (B)(6) 2019. FOR SAMPLE (B)(6), THE INITIAL COBAS MPX RESULT ON (B)(6) 2019 WAS HBV REACTIVE WITH A CT VALUE OF 40.45. A REDRAW WAS PERFORMED ON (B)(6) 2019, AND THE SAMPLE WAS DIVIDED INTO FOUR ALIQUOTS. THREE ALIQUOTS WERE STORED IN THE REFRIGERATOR AT 4°C AFTER CENTRIFUGATION, AND ONE ALIQUOT WAS FROZEN. TESTING OF THE THREE REFRIGERATED ALIQUOTS RESULTED IN INVALID RESULTS (TWO WITH INTERNAL CONTROL (IC) FLAGS AND ONE WITH A PO2T FLAG RELATED TO CLOTTING). THE FROZEN ALIQUOT PRODUCED A VALID NON-REACTIVE RESULT. FOR SAMPLE (B)(6), THE INITIAL COBAS MPX RESULT ON (B)(6) 2019 WAS HBV REACTIVE WITH A CT VALUE OF 38.68. A REDRAW WAS PERFORMED ON (B)(6) 2019, AND BOTH ALIQUOTS WERE STORED FROZEN BEFORE TESTING. TESTING OF ONE ALIQUOT RESULTED IN AN INVALID IC FLAG, WHILE THE OTHER ALIQUOT PRODUCED A VALID NON-REACTIVE RESULT. BY ITALIAN LAW, WHEN A SAMPLE IS INITIALLY TESTED WITH A REACTIVE RESULT, THE LABORATORY MUST TEST THE SAMPLE AN ADDITIONAL TWO TIMES. THE RESULTS FOR THESE TWO SAMPLES WERE NOT RELEASED AT THE CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531145 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG E31351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown