BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 25216766 · Received May 19, 2026

    Report

    Report Number
    1119779-2026-00791
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 21, 2026
    Report Date
    April 24, 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
    VM
    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 A PATIENT ISOLATE (STAPHYLOCOCCUS EPIDERMIDIS) WAS MISIDENTIFIED AS STAPHYLOCOCCUS AUREUS. THE USER VERIFIED THE FINAL RESULT USING BACTERIAL CULTURE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97800 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 NA Unknown