BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® MPX - 480T

    MDR report key: 23133670 · Received September 24, 2025

    Report

    Report Number
    2243471-2025-03548
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    April 21, 2020
    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
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED ON A COBAS 8800 ANALYZER (SERIAL NUMBER: (B)(6). THE INVESTIGATION DETERMINED THAT THE UNEXPECTED HIV REACTIVE RESULTS WERE MOST LIKELY DUE TO CONTAMINATION ASSOCIATED WITH THE INSTRUMENT OR WORKFLOW AT THE CUSTOMER SITE. THE SAMPLES ARE LIKELY FROM DONORS WHO ARE NOT INFECTED, AS SEROLOGY RESULTS FOR ALL DONORS WERE CONFIRMED TO BE NEGATIVE. A REVIEW OF THE DATA SHOWED THAT THE HIV-CT VALUES FOR THE COMPLAINT SAMPLES AND THE UNEXPECTED REACTIVE RESULT IN THE EXTERNAL NEGATIVE CONTROL WERE CONSISTENT WITH LOW-LEVEL VIRAL LOADS, WHICH COULD INDICATE CONTAMINATION OR A TRUE REACTIVE RESULT WITH A LOW VIRAL LOAD. HOWEVER, THE PRESENCE OF AN UNEXPECTED HIV REACTIVE RESULT IN THE NEGATIVE CONTROL AND THE GENERATION OF NON-REACTIVE RESULTS UPON REPEAT TESTING AFTER INSTRUMENT DECONTAMINATION STRONGLY SUPPORT CONTAMINATION AS THE MOST LIKELY ROOT CAUSE. THE CONTAMINATION MAY HAVE OCCURRED DURING THE HANDLING OF HIGH-TITER EXTERNAL CONTROLS OR DURING THE WORKFLOW FROM THE SAMPLE HANDLING AREA TO THE INSTRUMENT AREA. THE DEVICE REMAINS IN OPERATION AT THE CUSTOMER SITE, AND NO HARM WAS REPORTED IN ASSOCIATION WITH THIS EVENT.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED UNEXPECTED REACTIVE RESULTS WITH THE KIT COBAS 6800/8800 MPX 480T CE-IVD ASSAY ON THE COBAS 8800 INSTRUMENT. THE ALLEGATION INVOLVES FIVE HIV REACTIVE RESULTS GENERATED ON THE FOLLOWING DATES: ON (B)(6) 2020 (CT VALUE 38.17), ON (B)(6) 2020 (CT VALUE 39.03), ON (B)(6) 2020 (CT VALUE 38.49), AND TWO RESULTS ON (B)(6) 2020 (CT VALUES 38.57 AND 40.47). REPEAT TESTING OF THE SAME FIVE SAMPLES YIELDED NON-REACTIVE RESULTS, AND SEROLOGY FOR THE DONORS WAS CONFIRMED TO BE NEGATIVE. THE BLOOD WAS DISCARDED IN ACCORDANCE WITH THE CUSTOMER¿S PROCEDURE FOR INITIALLY REACTIVE RESULTS. FOLLOWING THESE EVENTS, THE CUSTOMER DECONTAMINATED THE INSTRUMENT ON (B)(6) 2020. SUBSEQUENTLY, TWO ADDITIONAL SAMPLES TESTED ON (B)(6) 2020 (CT VALUE 39.72) AND ON (B)(6) 2020 (CT VALUE 40.29) ALSO GENERATED UNEXPECTED HIV REACTIVE RESULTS. REPEAT TESTING OF THESE TWO SAMPLES YIELDED NON-REACTIVE RESULTS, SEROLOGY WAS CONFIRMED TO BE NEGATIVE, AND THE BLOOD WAS DISCARDED. ON (B)(6) 2020, AN UNEXPECTED HIV AMPLIFICATION WITH A CT VALUE OF 39.3 WAS OBSERVED IN THE NEGATIVE CONTROL, INVALIDATING THE RUN. THE RUN WAS REPEATED, AND VALID RESULTS WERE GENERATED. ADDITIONAL DATA PROVIDED BY THE CUSTOMER SHOWED FIVE MORE HIV REACTIVE RESULTS ON THE FOLLOWING DATES: ON (B)(6) 2020 (CT VALUE 40.87), ON (B)(6) 2020 (CT VALUE 40.87), ON (B)(6) 2020 (CT VALUES 39.81 AND 41.30), AND ON (B)(6) 2020 (CT VALUE 38.86). REPEAT TESTING OF THESE FIVE SAMPLES YIELDED NON-REACTIVE RESULTS, SEROLOGY WAS CONFIRMED TO BE NEGATIVE, AND THE BLOOD WAS NOT RELEASED IN ACCORDANCE WITH THE CUSTOMER¿S PROCEDURE FOR INITIALLY REACTIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2492942 COBAS® MPX - 480T ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA QHO ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG F03444

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown