BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 18903842 · Received March 14, 2024

    Report

    Report Number
    1119779-2024-00205
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    February 2, 2024
    Report Date
    August 2, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492922
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    INVESTIGATION SUMMARY THIS COMPLAINT IS FOR HIGH MIC ERTAPENEM (ETP) WITH ENTEROBACTER CLOACAE WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 3311874. THE CUSTOMER PROVIDED PHOENIX GENERATED LAB REPORTS AND AN ISOLATE BUT DID NOT PROVIDE PANEL RETURNS FOR THE INVESTIGATION. THE LAB REPORTS SHOW A RESISTANT RESULT FOR ETP WITH E. CLOACAE WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, THREE RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE E. CLOACAE AND PLACED IN A PHOENIX M50 FOR ETP MIC RESULTS. IN ADDITION, ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WAS INOCULATED WITH CUSTOMER RETURNED ISOLATE E. CLOACAE AND PLACED IN A PHOENIX M50 FOR ETP MIC RESULTS. LAST, KIRBY-BAUER TESTING WAS PERFORMED ON THE CUSTOMER RETURNED ISOLATE WITH ETP. RESULTS OF THE TEST SHOW ALL PANELS RETURNED THE EXPECTED RESULTS FOR ETP ACCORDING TO DISC DIFFUSION RESULTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD PHOENIX PANEL NMIC-306, ENTEROBACTER CLOACAE COMPLEX WAS FALSELY RESISTANT TO ERTAPENEM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD PHOENIX PANEL NMIC-306, ENTEROBACTER CLOACAE COMPLEX WAS FALSELY RESISTANT TO ERTAPENEM. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076729 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3311874 00382904492922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown