BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 25318298 · Received May 28, 2026

    Report

    Report Number
    1119779-2026-00870
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 13, 2026
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904436247
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K020321, K040099, K131331 AND K250344. H3. 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 WHILE USING THE BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD IDENTIFICATION RESULTS THAT DID NOT MATCH PARALLEL TESTING RESULTS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213883 BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) 00382904436247

    Patients

    Seq Age Sex Outcome Treatment
    1