BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 22938453 · Received September 2, 2025

    Report

    Report Number
    1119779-2025-04801
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    May 6, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G5. MULTIPLE 510K: 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. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC ERTAPENEM (ETP) WITH KLEBSIELLA PNEUMONIAE AND ESCHERICHIA COLI WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 4044887. THE CUSTOMER RETURNED ISOLATES BUT DID NOT RETURN PANELS BUT PROVIDED PHOENIX GENERATED LAB REPORTS AND ISOLATES FOR THE INVESTIGATION. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE HCCL-1, E. COLI HCCL-2, AND K. PNEUMONIAE HCCL-3 AND PLACED A PHOENIX M50 MACHINE TO EVALUATE FOR ETP MIC RESULTS. ALSO, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE HCCL-1, E. COLI HCCL-2, AND K. PNEUMONIAE HCCL-3 AND PLACED A PHOENIX M50 MACHINE TO EVALUATE FOR ETP MIC RESULTS. ALL PANELS TESTED RETURNED THE EXPECTED MIC RESULTS FOR ETP WITH THEIR RESPECTIVE ISOLATES. 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. 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 PATIENT SAMPLE GAVE A FALSE RESISTANT RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246256 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 4044887 00382904492922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown