BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 22577620 · Received July 23, 2025

    Report

    Report Number
    1119779-2025-01876
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    November 13, 2023
    Report Date
    June 12, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492892
    PMA / PMN Number
    SEE H11
    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 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 ISOLATE WAS VERIFIED AS E. COLI WITH BRUKER MALDI BIOTYPER. BATCH 3213033 WAS UNAVAILABLE FOR INVESTIGATION TESTING AND A COMPARABLE BATCH WAS USED FOR INVESTIGATION TESTING. TO INVESTIGATE, TWO COMPARABLE PANELS WERE TESTED USING CUSTOMER RETURNED ISOLATE E. COLI 9288288 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE E. COLI 9288288 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL THREE PANELS IDENTIFIED THE ISOLATE AS E. COLI; 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 SEVEN ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 3213033, SIX OF WHICH ARE RELATED TO THIS DEFECT AND UNCONFIRMED. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY 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 MISIDENTIFIED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2752990 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