BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANEL PHOENIX NMIC/ID-307

    MDR report key: 18318953 · Received December 13, 2023

    Report

    Report Number
    1119779-2023-01368
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 11, 2023
    Report Date
    February 7, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    30382904492893
    PMA / PMN Number
    SEE H10
    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

    H6: INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI WHEN USING PHOENIX PANEL NMIC/ID-307 (CATALOG NUMBER 449289) BATCH NUMBER 3213033. THE CUSTOMER RETURNED ISOLATES BUT DID NOT RETURN PHOENIX GENERATED LAB REPORTS OR PANELS FOR THE INVESTIGATION. THE ISOLATE WAS VERIFIED AS E. COLI WITH BRUKER MALDI BIOTYPER. BATCH 3213033 WAS UNAVAILABLE FOR INVESTIGATION TESTING AND A COMPARABLE BATCH WAS USED FOR INVESTIGATION TESTING. TO INVESTIGATE, TWO COMPARABLE PANELS WERE TESTED USING CUSTOMER RETURNED ISOLATE E. COLI 9288227 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, ONE CONTROL PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATE E. COLI 9288227 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. ALL THREE PANELS IDENTIFIED THE 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 FOUR ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 3213033, THREE OF WHICH ARE RELATED TO THIS DEFECT AND 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. G5. PMA / 510(K)#: THE PANEL PHOENIX NMIC/ID-307 IS AN ANTIMICROBIAL RESISTANCE PANEL THAT CONSISTS OF A COMBINATION OF THE FOLLOWING 510K NUMBERS: K020322, K023444, K023634, K023858, K024153, K031530, K031699, K032299, K032655, K033560, K041384, K042932, K052269, K060214, K060217, K060444, K060447, K060447, K061355, K062944, K063301, K063573, K063811, K063824, K071623, K132674, K151320.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT SAMPLE TESTED USING PANEL PHOENIX NMIC/ID-307 WAS MISIDENTIFIED. CUSTOMER REPEATED THE TEST AND ON SECOND RUN THE RESULTS CHANGED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT SAMPLE TESTED USING PANEL PHOENIX NMIC/ID-307 WAS MISIDENTIFIED. CUSTOMER REPEATED THE TEST AND ON SECOND RUN THE RESULTS CHANGED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980366 PANEL PHOENIX NMIC/ID-307 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 3213033 30382904492893

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown