BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-311

    MDR report key: 19470989 · Received June 5, 2024

    Report

    Report Number
    1119779-2024-00485
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    May 7, 2024
    Report Date
    July 30, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904494520
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 K061327 K061355 K062207 K062944 K063301 K063486 K063573 K063811 K063824 K071623 K123404 K132674 K132909 K151320 K173252 K190905 K163637 K173523 K033458 AND K123266. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR A PERFORMANCE ISSUE DUE TO NO MIC RESULTS FOR LEVOFLOXACIN (LVX) WHEN USING PHOENIX PANEL NMIC-311 (CATALOG NUMBER 449452) BATCH NUMBER 4031679. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS OR ISOLATES BUT PROVIDED BINARY FILES AND LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW INVALID AST RESULTS FOR LVX IN PATIENT SAMPLES. TO INVESTIGATE, THREE RETENTION PANELS EACH WERE INOCULATED WITH QC ISOLATES ESCHERICHIA COLI A25922 AND KLEBSIELLA PNEUMONIAE A70060 AND PLACED IN A PHOENIX M50 TO BE EVALUATED FOR LVX MIC RESULTS. ADDITIONALLY, TWO CONTROL PANELS EACH FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH QC ISOLATES ESCHERICHIA COLI A25922 AND KLEBSIELLA PNEUMONIAE A70060 AND PLACED IN A PHOENIX M50 TO BE EVALUATED FOR LVX MIC RESULTS. FOR A TOTAL OF TEN PANELS TESTED, ALL PANELS RETURNED VALID LVX AST RESULTS. THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF THE BINARY FILES WAS DETERMINED NOT TO BE REQUIRED BASED ON THE RESULTS OF THE INVESTIGATION. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. A REVIEW OF COMPLAINTS REVEALED THREE ADDITIONAL COMPLAINTS ON COMPLAINT BATCH 4031679, ONE OF WHICH IS RELATED TO THIS DEFECT AND UNCONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PANEL PHOENIX NMIC-311 NO MIC WAS GIVEN FOR THE DRUG LEVOFLOXACIN FOR A PATIENT, E. COLI, ISOLATE (504522864270). NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PANEL PHOENIX NMIC-311 NO MIC WAS GIVEN FOR THE DRUG LEVOFLOXACIN FOR A PATIENT, E. COLI, ISOLATE (504522864270). NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859077 BD PANEL PHOENIX NMIC-311 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 4031679 00382904494520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown