BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 22923684 · Received August 29, 2025

    Report

    Report Number
    1119779-2025-04620
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    November 10, 2023
    Report Date
    July 14, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492892
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G5. PMA / 510(K)#: THE PANEL PHOENIX NMIC/ID-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320 INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS CITROBACTER FERMERII WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 3213033. THE CUSTOMER RETURNED ISOLATES BUT DID NOT RETURN PHOENIX GENERATED LAB REPORTS OR PANELS FOR THE INVESTIGATION. THE CUSTOMER RETURNED ISOLATES WERE VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED K. AEROGENES 9288247-1, E. COLI 9288247-2 AND E. COLI 9288247-3. TO INVESTIGATE, TWO RETENTION PANELS EACH OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATE K. AEROGENES 9288247-1, E. COLI 9288247-2 AND E. COLI 9288247-3 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THEN, ONE CONTROL PANEL EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE K. AEROGENES 9288247-1, E. COLI 9288247-2 AND E. COLI 9288247-3 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL NINE PANELS IDENTIFIED THEIR INOCULATED ISOLATE CORRECTLY, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. THE BATCH HISTORY RECORD WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED FIVE ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 3213033, FOUR OF WHICH ARE RELATED TO THIS DEFECT BUT UNCONFIRMED. 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 PANEL PHOENIX NMIC/ID-307, A PATIENT SAMPLE WAS INCORRECTLY IDENTIFIED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163329 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 3213033 00382904492892

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown