BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 18266366 · Received December 5, 2023

    Report

    Report Number
    1119779-2023-01308
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    November 6, 2023
    Report Date
    July 12, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    K181665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ENTEROBACTER CLOACAE COMPLEX AS CITROBACTER FREUNDII WHEN USING PHOENIX PANEL NMIC/ID-307(CATALOG NUMBER 449289) BATCH NUMBER 3143180. THE CUSTOMER DID NOT RETURN PANELS OR PHOENIX GENERATED LAB REPORTS BUT PROVIDED ISOLATES FOR THE INVESTIGATION. THE CUSTOMER RETURNED ISOLATE WAS VERIFIED AS ENTEROBACTER HORMAECHEI ON THE BRUKER MALDI BIOTYPER. TO INVESTIGATE, FIVE RETENTION PANELS FROM COMPLAINT BATCH 3143180 WERE TESTED USING CUSTOMER RETURNED ISOLATE E. CLOACAE ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING CUSTOMER RETURNED ISOLATE E. CLOACAE ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. FOUR OF THE FIVE RETENTION PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATE AS CITROBACTER SPP. AND THE FIFTH PANEL RETURNED THE EXPECTED E. CLOACAE IDENTIFICATION. THEREFORE, THIS COMPLAINT IS CONFIRMED FOR MISIDENTIFICATION. AS PART OF THE INVESTIGATION, R&D PERFORMED A BIOCHEMICAL ANALYSIS OF THE BD TESTING LAB REPORTS AND BINARY FILES OF CUSTOMER RETURNED E. CLOACAE COMPLEX. REVIEW OF THE LAB REPORTS AND BINARY FILES FROM BD¿S INTERNAL TESTING SHOWS VARIABILITY IN SOME OF THE SUBSTRATE REACTIONS. THIS INDICATES THAT SOME OF THE SUBSTRATE REACTIONS WERE MORE ALIGNED WITH A C. FREUNDII IDENTIFICATION AS OPPOSED TO AN E. CLOACAE IDENTIFICATION HOWEVER, BASED ON THE ANALYSIS, THERE WERE NO RESULTS THAT STOOD OUT TO BE A DEFINITIVE CAUSE OF THE E. CLOACAE MIS IDS. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. THE BATCH HISTORY RECORD WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 3143180. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307 F E. CLOACAE MISIDENTIFIED AS C. FREUNDII. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PANEL PHOENIX NMIC/ID-307 F E. CLOACAE MISIDENTIFIED AS C. FREUNDII. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235301 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 3143180 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown