BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 18310285 · Received December 12, 2023

    Report

    Report Number
    1119779-2023-01350
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    November 21, 2023
    Report Date
    May 28, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492922
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. G5. 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, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, K063824, K071623, K132674, K132909, K151320, K163637, K173252, K173523, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K181665, K190905. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR FALSE POSITIVE CARBAPENEM RESISTANT ENTEROBACTERIAECEAE (CRE) RESULTS WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH 3192114. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS BUT PROVIDED ISOLATE RETURNS AND PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW POSITIVE CRE RESULTS FOR KLEBSIELLA PNEUMONIAE, ESCHERICHIA COLI, AND CITROBACTER KOSERI WHEN USING THE COMPLAINT BATCH. THE CUSTOMER RETURNED TWO K. PNEUMONIAE ISOLATES AND ONE E. COLI ISOLATE. TO INVESTIGATE, TWO RETENTION PANELS EACH FROM COMPLAINT BATCH 3192114 WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE #1, K. PNEUMONIAE #2, AND E. COLI TO OBSERVE FOR CRE RESULTS. IN ADDITION, ONE CONTROL PANEL EACH FROM THE SAME MATERIAL BUT A DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE #1, K. PNEUMONIAE #2, AND E. COLI TO OBSERVE FOR CRE RESULTS. THE INVESTIGATION RETURNED ALL NINE PANELS CLASSIFYING AS CRE NEGATIVE; 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. A REVIEW OF COMPLAINTS REVEALED NO OTHER COMPLAINTS ON THIS BATCH. 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 WHEN USING THE BD PHOENIX PANEL NMIC-306 PATIENT ISOLATE OF E. COLI WAS REPORTED AS FALSE POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). REPORT 2 OF 5.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PHOENIX PANEL NMIC-306 PATIENT ISOLATE OF E. COLI WAS REPORTED AS FALSE POSITIVE FOR CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). REPORT 2 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579832 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) UNKNOWN 00382904492922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown