BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-311

    MDR report key: 22739617 · Received August 7, 2025

    Report

    Report Number
    1119779-2025-02557
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 14, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904494521
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. 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, K033458, K033560, K041384, K042932, K052269, K060214, K060217, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, AND K06382. 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

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR FALSE POSITIVE ESBL RESULTS WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER 5127465. CUSTOMER RETURNED PANELS, ISOLATES OR PHOENIX GENERATED LAB REPORTS WERE NOT AVAILABLE FOR THE INVESTIGATION. IT IS TO BE NOTED THAT THE NMIC-311 DOES NOT INCLUDE CPO DETECT. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS OF THE SAME MATERIAL BUT DIFFERENT BATCH NUMBER WERE INOCULATED WITH IN HOUSE ISOLATE ESCHERICHIA COLI A25922 AND PLACED IN A PHOENIX M50 TO OBSERVE FOR ESBL FLAGS. ALL PANELS RETURNED THE ISOLATE WITH ESBL NEGATIVE RESULTS; THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. THE BATCH HISTORY RECORD WAS 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-311 THE USER NOTED THAT THERE WAS AN INCREASE IN EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) AND CARBAPENEM RESISTANT ISOLATES. ADDITIONALLY, THE USER NOTED QC FAILURES ASSOCIATED WITH HIGH MICS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 5 OF 8.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 THE USER NOTED THAT THERE WAS AN INCREASE IN EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) AND CARBAPENEM RESISTANT ISOLATES. ADDITIONALLY, THE USER NOTED QC FAILURES ASSOCIATED WITH HIGH MICS. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 5 OF 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501219 BD PHOENIX¿ NMIC-311 SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 5127465 30382904494521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown