BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 22953166 · Received September 3, 2025

    Report

    Report Number
    1119779-2025-04890
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    June 2, 2024
    Report Date
    July 10, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492922
    PMA / PMN Number
    SEE H.11
    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

    G5. MULTIPLE 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 HIGH MIC MEROPENEM (MEM) AND ERTAPENEM (ETP) WITH CITROBACTER WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 4100303. THE CUSTOMER DID NOT PROVIDE ISOLATES OR PANEL RETURNS BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW HIGH MIC MEM AND ETP WITH CITROBACTER WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, THREE RETENTION PANELS FROM THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE CITROBACTER FREUNDII ENF 10852 THEN PLACED IN A PHOENIX M50 FOR MEM AND ETP MIC RESULTS. IN ADDITION, TWO CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATE CITROBACTER FREUNDII ENF 10852 THEN PLACED IN A PHOENIX M50 FOR MEM AND ETP MIC RESULTS. RESULTS OF THE INVESTIGATION RETURNED ALL PANELS WITH THE EXPECTED MIC FOR MEM AND ETP. 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. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHOENIX PANEL NMIC-306, A SAMPLE GAVE DIFFERENT RESULTS WHEN RETESTED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474301 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 4100303 00382904492922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown