BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PHOENIX NID

    MDR report key: 12125874 · Received July 6, 2021

    Report

    Report Number
    1119779-2021-01140
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    May 26, 2021
    Report Date
    August 16, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LQM
    UDI-DI
    30382904480074
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF BURKHOLDERIA PSEUDOMALLEI AS STENOTROPHOMONAS MALTOPHILIA WHEN USING PHOENIX PANEL NID (448007) BATCH NUMBER 1053136. THE CUSTOMER DID RETURN LAB REPORTS FOR INVESTIGATION. IT IS TO BE NOTED THAT BD DOES NOT HAVE CLAIMS ON FEDERAL SELECT AGENTS. BURKHOLDERIA PSEUDOMALLEI IS CONSIDERED A SELECT AGENT. THIS INFORMATION CAN BE FOUND AT THE FOLLOWING WEBSITE : HTTPS://WWW.SELECTAGENTS.GOV/SAT/LIST.HTM?CDC_AA_REFVAL=HTTPS%3A%2F%2FWWW.SELECTAGENTS.GOV%2FSELECTAGENTSANDTOXINSLIST.HTML. SINCE BD DOES NOT HAVE CLAIMS ON THE ORGANISM THAT WAS MISIDENTIFIED, THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON THIS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 2 BD PHOENIX¿ NID MISIDENTIFICATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE PATIENT WAS TREATED WITH STENOTROPHOMONAS MALTOPHILIA AND LATER CHANGED TO BURKHOLDERIA DUE TO THE CORRECTION OF THE RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MALDI WAS DOWN AS A RESULT THE ISOLATE WAS RUN ON PHOENIX AND THE SAME IS BEEN IDENTIFIED AS STENOTROPHOMONAS MALTOPHILI"

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT WHILE USING 2 BD PHOENIX¿ NID MISIDENTIFICATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THE PATIENT WAS TREATED WITH STENOTROPHOMONAS MALTOPHILIA AND LATER CHANGED TO BURKHOLDERIA DUE TO THE CORRECTION OF THE RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MALDI WAS DOWN AS A RESULT THE ISOLATE WAS RUN ON PHOENIX AND THE SAME IS BEEN IDENTIFIED AS STENOTROPHOMONAS MALTOPHILIA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021056 BD PHOENIX NID GRAM NEGATIVE IDENTIFICATION PANEL LQM BECTON, DICKINSON & CO. (SPARKS) 448007 1053136 30382904480074

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention