BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® HIV-1

    MDR report key: 22914127 · Received August 28, 2025

    Report

    Report Number
    2243471-2025-02640
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    May 22, 2024
    Report Date
    August 28, 2025
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    MZF
    UDI-DI
    00875197006407
    PMA / PMN Number
    BP150262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). A BATCH TREND WAS NOT IDENTIFIED FOR THE ALLEGED KIT LOT K00224. A HOLISTIC VIEW OF THE REAGENTS AND THE REAGENT KIT DOES NOT INDICATE A PRODUCT PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, THE DISCREPANCY IS CONSISTENT WITH A CONTAMINATION OF THE PRIMARY TUBE AS BOTH TESTS WERE OUT OF THE SAME TUBE, WITH THE LOWER TITER BEING SECOND AFTER A FREEZE/THAW AND POTENTIAL TIME AT ROOM TEMPERATURE/MORE HANDLING. THE CUSTOMER ALSO AGREED THAT CONTAMINATION IS THE MOST LIKELY CONTRIBUTOR AS ONE OF THE SAMPLES IN THE RUN WAS AT A VERY HIGH TITER (TITER ABOVE RANGE). THE INVESTIGATION DETERMINED THAT THE DIFFERENCES OBSERVED ARE SAMPLE-SPECIFIC. INADVERTENT CONTAMINATION IS PLAUSIBLE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF DISCREPANT COBAS® HIV-1 RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8800 ANALYZER. ON (B)(6) 2024, THE INITIAL RESULT WAS 82,000 CP/ML. THIS RESULT WAS UNEXPECTED AS THE PATIENT IS USUALLY AROUND 134 CP/ML. ON (B)(6) 2024, THE SAME SAMPLE TUBE WAS REPEATED AND THE RESULT WAS 13,600 CP/ML. DATE UNKNOWN, A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND THE RESULT WAS ACCORDING TO THE EXPECTED VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520584 COBAS® HIV-1 HUMAN IMMUNODEFICIENCY VIRUS (HIV) VIRAL LOAD MONITORING TEST MZF ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG K00224 00875197006407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown