BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PANEL PHOENIX NMIC-311

    MDR report key: 16577106 · Received March 20, 2023

    Report

    Report Number
    1119779-2023-00298
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    March 2, 2023
    Report Date
    April 21, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LON
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FOR PERFORMANCE ISSUES DUE TO HIGH MIC RESULTS FOR CEFTAZIDINE (CAZ) AND CEFTAZIDINE-AVIBACTAM (CZA) WHEN USING PHOENIX PANEL NMIC-311 (449452) BATCH NUMBER 2319748 . THE CUSTOMER DID NOT PROVIDE PANEL RETURNS, ISOLATES OR PHOTOS BUT RETURNED LAB REPORTS FOR THE INVESTIGATION. TO INVESTIGATE, THREE (3) RETENTION PANELS FROM THE COMPLAINT BATCH WAS INOCULATED WITH QC ISOLATE E. COLI (A25922) AND EVALUATED IN A PHOENIX M50 FOR CZA AND CAZ MIC RESULTS. ALSO, ONE (1) RETENTION PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WAS INOCULATED WITH QC ISOLATE E. COLI (A25922) AND EVALUATED IN A PHOENIX M50 FOR CZA AND CAZ MIC RESULTS. NEXT, THREE (3) RETENTION PANELS FROM THE COMPLAINT BATCH WAS INOCULATED WITH QC ISOLATE K. PNEUMONIAE (14780) AND EVALUATED IN A PHOENIX M50 FOR CZA AND CAZ MIC RESULTS. ALSO, ONE (1) RETENTION PANEL FROM THE SAME MATERIAL BUT DIFFERENT BATCH WAS INOCULATED WITH QC ISOLATE K. PNEUMONIAE (14780) AND EVALUATED IN A PHOENIX M50 FOR CZA AND CAZ MIC RESULTS. THE INVESTIGATION RETURNED THE EXPECTED MIC RESULTS, THEREFORE, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED ONE (1) ADDITIONAL COMPLAINT ON THE COMPLAINT BATCH, NOT RELATED TO THIS DEFECT. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. A BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THIS DEFECT. PLEASE CONTINUE TO COMMUNICATE ADDITIONAL CONCERNS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    (B)(6). 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 BD PANEL PHOENIX NMIC-311 DISCREPANCY IN RESULTS HAS OCCURRED FOR CEFTAZIDINE AND CEFTAZIDINE-AVIBACTAM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS INQUIRING IF ATTACHED REPORTS SHOWS A DISCREPANT RESULT FOR CEFTAZIDINE AND CEFTAZIDINE-AVIBACTAM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PANEL PHOENIX NMIC-311 DISCREPANCY IN RESULTS HAS OCCURRED FOR CEFTAZIDINE AND CEFTAZIDINE-AVIBACTAM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS INQUIRING IF ATTACHED REPORTS SHOWS A DISCREPANT RESULT FOR CEFTAZIDINE AND CEFTAZIDINE-AVIBACTAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11048 BD PANEL PHOENIX NMIC-311 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON, DICKINSON & CO. (SPARKS) 2319748

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown