BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 23706486 · Received December 3, 2025

    Report

    Report Number
    1119779-2025-05476
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 10, 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
    FR
    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 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, AN UNSPECIFIED NUMBER OF FALSE NEGATIVE SARS-COV2 RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857660 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY OOI BECTON, DICKINSON & CO. (SPARKS) 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown