BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 18817350 · Received March 1, 2024

    Report

    Report Number
    1119779-2024-00161
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    November 2, 2023
    Report Date
    February 1, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492892
    PMA / PMN Number
    K181665
    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

    H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS CITROBACTER KOSERI, CITROBACTER FERMERII OR ENTEROBACTER CLOACAE WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 3213033. THE CUSTOMER RETURNED ISOLATES AND PANELS BUT DID NOT RETURN PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE CUSTOMER RETURNED ISOLATES WERE VERIFIED ON A BRUKER MALDI BIOTYPER AND LABELED AS E. COLI SJ-1 THROUGH SJ-4. COMPLAINT BATCH 3213033 WAS UNAVAILABLE FOR INVESTIGATION TESTING AND A COMPARABLE BATCH WAS USED. TO INVESTIGATE, TWO COMPARABLE PANELS EACH WERE TESTED USING CUSTOMER RETURNED ISOLATES E. COLI SJ-1THROUGH SJ-4 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THEN, ONE CONTROL PANEL EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES E. COLI SJ-1THROUGH SJ-4 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL TWELVE PANELS IDENTIFIED THEIR ISOLATE AS E. COLI, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED FOR MISIDENTIFICATION. THE BATCH HISTORY RECORD WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED FIVE ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 3213033, FOUR OF WHICH ARE RELATED TO THIS DEFECT BUT UNCONFIRMED. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307 ESCHERICHIA COLI WAS MISIDENTIFIED AS CITROBACTER FARMERI. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 4 OF 4

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909144 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3213033 00382904492892

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown