BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-311

    MDR report key: 20745571 · Received November 21, 2024

    Report

    Report Number
    1119779-2024-00913
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    August 31, 2024
    Report Date
    December 11, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904494521
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. 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, K123404, K132674, K132909, K151320, 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THIS COMPLAINT IS FOR FALSE RESISTANCE TO CARBAPENEMS WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER 4192399. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS BUT PROVIDED ISOLATES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW KLEBSIELLA PNEUMONIAE AND PROTEUS MIRABILIS WITH VARIED CARBAPENEM MICS WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, RETENTION PANELS OF COMPLAINT BATCH 4192399 WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE D1, K. PNEUMONIAE D11, P. MIRABILIS C1 AND P. MIRABILIS C2 AND EVALUATED FOR CARBAPENEM MIC RESULTS. IN ADDITION, ONE CONTROL PANEL EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE D1, K. PNEUMONIAE D11, P. MIRABILIS C1 AND P. MIRABILIS C2 AND EVALUATED FOR CARBAPENEM MIC RESULTS. ALL PANELS TESTED RETURNED THE EXPECTED MICS FOR CARBAPENEMS, THEREFORE, 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 ASSOCIATED WITH THIS DEFECT. PLEASE CONTINUE TO COMMUNICATE ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD HIGH MICS FOR CARBAPENEMS. THE USER NOTED THAT SPECIFIC DRUGS LIKE, ERTAPENEM AND MEROPENEM, ARE RESISTANT BUT ARE NOT WITH REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-311 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD HIGH MICS FOR CARBAPENEMS. THE USER NOTED THAT SPECIFIC DRUGS LIKE, ERTAPENEM AND MEROPENEM, ARE RESISTANT BUT ARE NOT WITH REPEAT TESTING. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430512 BD PHOENIX¿ NMIC-311 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4192399 30382904494521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown