BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 20365025 · Received October 3, 2024

    Report

    Report Number
    1119779-2024-00721
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    August 30, 2024
    Report Date
    October 30, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904436247
    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 ERTAPENEM (ETP) WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 4199980. THE CUSTOMER DID NOT PROVIDE ISOLATES OR PANEL RETURNS BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW HIGH MIC ETP WITH KLEBSIELLA PNEUMONIAE, KLEBSIELLA VARIICOLA, PROVIDENCIA STUARTII AND ENTEROBACTER CLOACAE COMPLEX WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, TWO RETENTION PANELS EACH FROM THE COMPLAINT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES K. PNEUMONIAE ENF 11000, K. VARIICOLA ENF 22211, P. STUARTII ENF 9508 AND E. CLOACAE COMPLEX ENF 9907 THEN PLACED IN A PHOENIX M50 FOR ETP MIC RESULTS. IN ADDITION, ONE CONTROL PANEL EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES K. PNEUMONIAE ENF 11000, K. VARIICOLA ENF 22211, P. STUARTII ENF 9508 AND E. CLOACAE COMPLEX ENF 9907 THEN PLACED IN A PHOENIX M50 FOR ETP MIC RESULTS. RESULTS OF THE INVESTIGATION RETURNED ALL PANELS WITH THE EXPECTED SUSCEPTIBLE MIC RESULTS FOR ETP. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-306 THAT A PATIENT ISOLATE (K. VARIICOLA) FROM A URINE SAMPLE HAD A HIGH MIC FOR THE DRUG ERTAPENEM. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 4.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-306 THAT A PATIENT ISOLATE (K. VARIICOLA) FROM A URINE SAMPLE HAD A HIGH MIC FOR THE DRUG ERTAPENEM. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403580 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 4199980 00382904436247

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown