BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM

    MDR report key: 22964613 · Received September 4, 2025

    Report

    Report Number
    1119779-2025-04923
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 8, 2025
    Report Date
    September 10, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904481001
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K020321, K020322, K020323, K040099, AND K131331. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER INDICATING THAT NO PATIENT RESULTS WERE AFFECTED. THIS COMPLAINT IS NOT MDR REPORTABLE. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THE PREVIOUS MFR REPORT #1119779-2025-04923 SHOULD BE CONSIDERED CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM A PATIENT ISOLATE HAD ABNORMAL ANTIMICROBIAL SUSCEPTIBILITY RESULTS. NO FURTHER INFORMATION WAS PROVIDED. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675736 BD PHOENIX¿ AUTOMATED MICROBIOLOGY SYSTEM SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 00382904481001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown