BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 20053359 · Received August 23, 2024

    Report

    Report Number
    1119779-2024-00632
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 24, 2024
    Report Date
    October 28, 2024
    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

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR LOW MIC MEROPENEM-VABORBACTAM (MEV) WITH KLEBSIELLA PNEUMONIAE WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 4156362. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS, ISOLATE RETURNS OR PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. TO INVESTIGATE, THREE RETENTION PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS WERE INOCULATED WITH IN HOUSE ISOLATE K. PNEUMONIAE ENF 19553 AND PLACED IN A PHOENIX M50 FOR MEV MIC RESULTS AND ESBL FLAGS. RESULTS OF THE TEST SHOW ALL PANELS RETURNED THE EXPECTED MIC RESULTS FOR MEV AND ESBL POSITIVE FLAGS. 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.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G5. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-306 A PATIENT ISOLATE K. PNEUMONIAE FROM A URINE SAMPLE GAVE A RESULT FOR THE DRUG MEROPENEM/VABORBACTAM AS SUSCEPTIBLE (LOW MIC), BUT THE DRUG MEROPENEM WAS RESISTANT. THE USER VERIFIED THE RESULT WITH AN E-TEST AND IT WAS RESISTANT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-306 A PATIENT ISOLATE K. PNEUMONIAE FROM A URINE SAMPLE GAVE A RESULT FOR THE DRUG MEROPENEM/VABORBACTAM AS SUSCEPTIBLE (LOW MIC), BUT THE DRUG MEROPENEM WAS RESISTANT. THE USER VERIFIED THE RESULT WITH AN E-TEST AND IT WAS RESISTANT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387879 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 4156362 00382904492922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown