BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-306

    MDR report key: 22184487 · Received June 11, 2025

    Report

    Report Number
    1119779-2025-00566
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    May 16, 2025
    Report Date
    May 28, 2025
    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

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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, K031530, K031699, K031912, K032299, K032567, K032655, K033362, K033560, K041384, K042932, K052269, K060214, K060217, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, K063824, K071623, K132674, K132909, K151320, K181665, K173252, K190905, K163637, K173523, K033458, AND K123266. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR FALSE NEGATIVE ESBL RESULTS FOR PROTEUS MIRABILIS WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 5003211. THE CUSTOMER DID NOT PROVIDE PRODUCT RETURNS, ISOLATE RETURNS OR PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. IT IS TO BE NOTED THAT BD PHOENIX ESBL TEST IS APPLIED TO E. COLI, K. PNEUMONIAE AND K. OXYTOCA. THERE ARE NO CLAIMS FOR PROTEUS MIRABILIS. THIS COMPLAINT IS UNCONFIRMED. THE BATCH HISTORY RECORDS WERE SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 A PATIENT ISOLATE (PROTEUS MIRABILIS) WAS NOT REPORTED FOR EXTENDED SPECTRUM BETA-LACTAMASE (ESBL) RESULTS (FALSE NEGATIVE). IT IS TO BE NOTED THAT PROTEUS SPP. IS ONLY IN USE FOR RESEARCH/DEVELOPMENT FOR ESBL. THE ESBL RESULT IS ONLY APPLIED TO ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE AND KLEBSIELLA OXYTOCA, PER THE USER MANUAL. THE USER NOTED THAT ALL OF THE EFFECT PATIENTS WERE NOT IN ISOLATED ROOMS. REPORT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69781 BD PHOENIX¿ NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5003211 30382904492923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown