BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-306

    MDR report key: 25301424 · Received May 27, 2026

    Report

    Report Number
    1119779-2026-00861
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 6, 2026
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492923
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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)#: K020322, K022129, K023444, K023634, K023858, K024153, 031530, K031699, K031912, K032299, K032567, K032655, K032675, K033362, K033458, K033558, K033560, K041384, K042932, K052269, K060214, 060217, K060257, K060444, K060447, K061327, K061355, K061867, K062207, K062944, K063301, AND K06348. UNKNOWN LOT NUMBER: D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 A PATIENT URINE ISOLATE (PSEUDOMONAS AERUGINOSA) HAD A HIGH MIC (FALSE RESISTANT) RESULT. THE USER STATED THAT THE P. AERUGINOSA WAS IDENTIFIED AS A CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563436 BD PHOENIX¿ NMIC-306 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON, DICKINSON & CO. (SPARKS) UNKNOWN 30382904492923

    Patients

    Seq Age Sex Outcome Treatment
    1