BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 23867554 · Received December 22, 2025

    Report

    Report Number
    1119779-2025-05525
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    38290441916098
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: NQX, NJR, OZN. E.1. INITIAL REPORTER PHONE #: (B)(6). E.1. INITIAL REPORTER FAX #: (B)(6). 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 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, A FALSE NEGATIVE MDR-TB PATIENT RESULT WAS OBTAINED. SAMPLE WAS ALSO RUN ON BD BACTEC¿ AND MDR-TB WAS DETECTED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605486 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY OOI BECTON, DICKINSON & CO. (SPARKS) 38290441916098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown