BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NID

    MDR report key: 16512746 · Received March 9, 2023

    Report

    Report Number
    1119779-2023-00251
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 20, 2023
    Report Date
    April 7, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LQM
    UDI-DI
    30382904480074
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY THIS COMPLAINT IS FOR MIS-IDENTIFICATION OF ACINETOBACTER BAUMANII AS MORAXELLA CATHATTALIS WHEN USING PHOENIX PANEL NID ((B)(4)) BATCH NUMBER 2110791. THE CUSTOMER DID NOT PROVIDE ISOLATE RETURNS, LAB REPORTS OR PANEL RETURNS FOR THE INVESTIGATION. TO INVESTIGATE, FOUR (4) RETENTION SAMPLES OF THE COMPLAINT BATCH WERE INOCULATED WITH QC ISOLATE ACINETOBACTER BAUMANII 15748 AND EVALUATED IN A PHOENIX M50 FOR IDENTIFICATION RESULTS. ALL FOUR (4) PANELS IDENTIFIED THE ISOLATES AS A. BAUMANII OR A. BAUMANII/CALCOACETICUS COMPLEX, THEREFORE THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS FOR THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON THE COMPLAINT BATCH. 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. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    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 PHOENIX¿ NID MISIDENTIFIED ACINETOBACTER BAUMANII AS MORAXELLA CATHATTALIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACINETOBACTER BAUMANII WAS IDENTIFIED AS MORAXELLA CATHATTALIS NO IMPACT ON THE PATIENT

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHOENIX¿ NID MISIDENTIFIED ACINETOBACTER BAUMANII AS MORAXELLA CATHATTALIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACINETOBACTER BAUMANII WAS IDENTIFIED AS MORAXELLA CATHATTALIS. NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716916 BD PHOENIX¿ NID GRAM NEGATIVE IDENTIFICATION PANEL LQM BECTON, DICKINSON & CO. (SPARKS) 448007 2110791 30382904480074

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown