BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-306

    MDR report key: 21698698 · Received March 26, 2025

    Report

    Report Number
    1119779-2025-00217
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    February 18, 2025
    Report Date
    May 27, 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
    NJ, US
    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)#: 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. 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 HIGH MIC ERTAPENEM (ETP) WITH ENTEROBACTER CLOACAE COMPLEX WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 4353531. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS OR ISOLATES BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW HIGH MIC RESULTS FOR ETP WITH ENTEROBACTER CLOACAE COMPLEX WHEN USING THE COMPLAINT BATCH. THE LAB REPORTS ALSO NOTE ACINETOBACTER BAUMANII/CALCOACITECUS COMPLEX WITH INTRINSIC RESISTANCE TO ETP. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE ENTEROBACTER CLOACAE COMPLEX ENF 11061 AND PLACED IN A PHOENIX M50 TO EVALUATE FOR ETP MIC RESULTS. NEXT, CONTROL PANELS OF THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE ENTEROBACTER CLOACAE COMPLEX ENF 11061 AND PLACED IN A PHOENIX M50 TO EVALUATE FOR ETP MIC RESULTS. AT THE END OF THE RUN, ALL PANELS RETURNED THE EXPECTED ETP MIC RESULTS. 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-306 A PATIENT ISOLATE (ENTEROBACTER CLOACAE COMPLEX) HAD A RESISTANT (HIGH MIC) RESULT FOR THE DRUG ERTAPENEM WHILE THE E-TEST USED AS A CONFIRMATORY TEST WAS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 5.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 A PATIENT ISOLATE (ENTEROBACTER CLOACAE COMPLEX) HAD A RESISTANT (HIGH MIC) RESULT FOR THE DRUG ERTAPENEM WHILE THE E-TEST USED AS A CONFIRMATORY TEST WAS SENSITIVE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113588 BD PHOENIX¿ NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4353531 30382904492923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown