BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NMIC-306

    MDR report key: 21305314 · Received February 4, 2025

    Report

    Report Number
    1119779-2025-00030
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    December 17, 2024
    Report Date
    April 3, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492923
    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

    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, 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - THIS COMPLAINT IS FOR HIGH MIC MEROPENEM (MEM) WITH KLEBSIELLA PNEUMONIAE, ESCHERICHIA COLI AND ENTEROBACTER CLOACAE COMPLEX WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 4317031. THE CUSTOMER DID NOT RETURN PANELS BUT RETURNED ISOLATES, PHOENIX GENERATED LAB REPORTS AND BINARY FILES FOR THE INVESTIGATION. THE PHOENIX GENERATED LAB REPORTS SHOW HIGH MIC MEM WITH KLEBSIELLA PNEUMONIAE, ESCHERICHIA COLI AND ENTEROBACTER CLOACAE COMPLEX WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES KLEBSIELLA PNEUMONIAE N820901067, E. COLI N825007857, E. CLOACAE COMPLEX N824019728, E. CLOACAE COMPLEX N823011694, K. PNEUMONIAE N824011063, K. PNEUMONIAE N823011300 AND E. COLI N825015335 ON A PHOENIX M50 MACHINE AND EVALUATED FOR MEM MIC RESULTS. ALSO, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATES KLEBSIELLA PNEUMONIAE N820901067, E. COLI N825007857, E. CLOACAE COMPLEX N824019728, E. CLOACAE COMPLEX N823011694, K. PNEUMONIAE N824011063, K. PNEUMONIAE N823011300 AND E. COLI N825015335 ON A PHOENIX M50 MACHINE AND EVALUATED FOR MEM MIC RESULTS. ALL PANELS TESTED RETURNED THE EXPECTED SENSITIVE MICS FOR MEM, 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. 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 WHILE USING THE BD PHOENIX¿ NMIC-306 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD HIGH MICS FOR THE DRUG MEROPENEM. CONFIRMATORY TESTING WAS PERFORMED USING E-TEST STRIP. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NMIC-306 AN UNSPECIFIED NUMBER OF PATIENT ISOLATES HAD HIGH MICS FOR THE DRUG MEROPENEM. CONFIRMATORY TESTING WAS PERFORMED USING E-TEST STRIP. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64153 BD PHOENIX¿ NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION LON BECTON DICKINSON & CO. (SPARKS) 4317031 30382904492923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown