BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ NID

    MDR report key: 21442475 · Received February 23, 2025

    Report

    Report Number
    1119779-2025-00116
    Event Type
    Malfunction
    Date Received
    February 23, 2025
    Date of Event
    December 13, 2024
    Report Date
    May 14, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LQM
    UDI-DI
    30382904480074
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: D2A. COMMON DEVICE NAME: GRAM NEGATIVE IDENTIFICATION PANEL INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF ESCHERICHIA COLI AS SHIGELLA BOYDII WHEN USING PHOENIX PANEL NID (CATALOG NUMBER 448007) BATCH NUMBERS 4233375 AND 4254922. THE CUSTOMER DID NOT RETURN PANELS OR ISOLATES BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF SERRATIA MARCESCENS AS SERRATIA LIQUEFACIENS, CITROBACTER KOSERI AS ESCHERICHIA COLI AND PSEUDOMONAS AERUGINOSA AS OLIGELLA UREOLYTICA. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATES P. AERUGINOSA 10414, C. KOSERI 8869, E. COLI 12925 AND S. MARCESCENS 9978 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATES CORRECTLY, THIS COMPLAINT IS NOT CONFIRMED. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. 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. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NID A PATIENT ISOLATE (ESCHERICHIA COLI) WAS MISIDENTIFIED AS SHIGELLA BOYDII. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ NID A PATIENT ISOLATE (ESCHERICHIA COLI) WAS MISIDENTIFIED AS SHIGELLA BOYDII. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472077 BD PHOENIX¿ NID GRAM NEGATIVE IDENTIFICATION PANEL LQM BECTON DICKINSON & CO. (SPARKS) 4233375 30382904480074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female