BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-311

    MDR report key: 18639459 · Received February 5, 2024

    Report

    Report Number
    1119779-2024-00070
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 10, 2024
    Report Date
    June 12, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904494520
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5. PMA/510(K)#: THE PANEL PHOENIX NMIC/ID-311 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K032299, K061355, K061327, K031912, K023444, K063824, K033560, K063573, K041384, K060217, K052269, K190905, K032655, K062944, K060444, K173252, K033362, K062207, K063811, K163637, K151320, K063301, K031530, K060447, K032567, K060257, K023634, K123404, K020322, K132674, K173523, K063486, K022129, K023858, K071623, K031699, K060447, K024153, K060214, K132909, K042932. H.3. 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

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC ERTAPENEM (ETP) AND CEFTAZIDIME (CAZ) WITH ESCHERICHIA COLI WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER 3241572. THE CUSTOMER PROVIDED PANEL RETURNS, ISOLATE RETURNS, BINARY FILES AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW A RESISTANT RESULT FOR ETP AND CAZ WITH E. COLI WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, ONE CUSTOMER RETURNED PANEL EACH OF THE COMPLAINT BATCH WERE INOCULATED WITH EACH CUSTOMER RETURNED ISOLATE E. COLI # 15, E. COLI # 46 AND E. COLI #84 AND PLACED IN A PHOENIX M50 FOR ETP AND CAZ MIC RESULTS. IN ADDITION, ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WAS INOCULATED WITH CUSTOMER RETURNED ISOLATE E. COLI # 15, E. COLI # 46 AND E. COLI #84 AND PLACED IN A PHOENIX M50 FOR ETP AND CAZ MIC RESULTS. RESULTS OF THE TEST SHOW ALL PANELS RETURNED THE EXPECTED RESULTS FOR ETP AND CAZ. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. 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. A REVIEW OF COMPLAINTS REVEALED ONE OTHER COMPLAINT ON THIS BATCH, RELATED TO THIS DEFECT AND UNCONFIRMED. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD PANEL PHOENIX NMIC-311, CEFTAZIDIME AND ERTAPENEM WERE SENSITIVE, BUT UPON REPEAT THEY WERE RESISTANT.THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD PANEL PHOENIX NMIC-311, CEFTAZIDIME AND ERTAPENEM WERE SENSITIVE, BUT UPON REPEAT THEY WERE RESISTANT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595826 BD PANEL PHOENIX NMIC-311 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 3241572 00382904494520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown