BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 23100010 · Received September 19, 2025

    Report

    Report Number
    1119779-2025-04995
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 25, 2025
    Report Date
    August 27, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: NQX, NJR, OZN. G.4. THERE WERE MULTIPLE PMA/510K NUMBERS: K111860, K120138, K130470. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF MAX SYSTEM, MAX INSTRUMENT, AN UNSPECIFIED NUMBER OF FALSE POSITIVE PATIENT RESULTS WERE OBTAINED. TESTS WERE REPEATED AND WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722463 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown