BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-311

    MDR report key: 18639816 · Received February 5, 2024

    Report

    Report Number
    1119779-2024-00072
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 7, 2024
    Report Date
    June 14, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904494520
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD PANEL PHOENIX NMIC-311 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: G5. PMA / 510(K)# 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, AND K042932. 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

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC ERTAPENEM (ETP) AND MEROPENEM (MEM) WITH ESCHERICHIA COLI AND KLEBSIELLA AEROGENES WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER 3304066. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS OR ISOLATE RETURNS BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW DISCREPANT RESULTS FOR ETP AND MEM WITH E. COLI AND K. AEROGENES WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES E. COLI ENF 1002 AND K. AEROGENES ENF 2174 AND PLACED IN A PHOENIX M50 FOR ETP AND MEM MIC RESULTS. IN ADDITION, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES E. COLI ENF 1002 AND K. AEROGENES ENF 2174 AND PLACED IN A PHOENIX M50 FOR ETP AND MEM MIC RESULTS. RESULTS OF THE TEST SHOW ALL PANELS RETURNED THE EXPECTED RESULTS FOR ETP AND MEM. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PANEL PHOENIX NMIC-311 A PATIENT SPUTUM ISOLATE HAD A HIGH MIC FOR THE DRUGS MEROPENEM AND ERTAPENEM WHEN COMPARED TO THE VITEK 2 INSTRUMENTATION AND KIRBY BAUER (KB) DISK RESULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PANEL PHOENIX NMIC-311 A PATIENT BLOOD ISOLATE HAD A HIGH MIC FOR THE DRUGS MEROPENEM AND ERTAPENEM WHEN COMPARED TO THE VITEK 2 INSTRUMENTATION AND KIRBY BAUER (KB) DISK RESULT. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1622294 BD PANEL PHOENIX NMIC-311 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3304066 00382904494520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown