BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PID

    MDR report key: 21446076 · Received February 24, 2025

    Report

    Report Number
    1119779-2025-00121
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    January 18, 2025
    Report Date
    April 16, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LQL
    UDI-DI
    30382904480081
    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

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION WHEN USING PHOENIX PANEL PID (CATALOG NUMBER 448008) BATCH NUMBER 4240517. THE CUSTOMER DID NOT RETURN PANELS OR ISOLATES BUT PROVIDED PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE LAB REPORTS SHOW IDENTIFICATIONS OF STAPHYLOCOCCUS AUREUS AS STAPHYLOCOCCUS EPIDERMIDIS, STAPHYLOCOCCUS EPIDERMIDIS AS STAPHYLOCOCCUS AUREUS AND STREPTOCOCCUS GORDONII AS STREPTOCOCCUS AGALACTIAE WHEN USING THE COMPLAINT BATCH. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE TESTED USING IN HOUSE ISOLATES S. AUREUS 4757, S. GORDONII POS 1843 AND S. AUREUS A43300 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. IN ADDITION, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH IN HOUSE ISOLATES S. GORDONII POS 1843 AND S. AUREUS A43300 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¿ PID A PATIENT ISOLATE (STREPTOCOCCUS GORDONII) WAS MISIDENTIFIED AS STREPTOCOCCUS AGALACTIAE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 3.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PID A PATIENT ISOLATE (STREPTOCOCCUS GORDONII) WAS MISIDENTIFIED AS STREPTOCOCCUS AGALACTIAE. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403214 BD PHOENIX¿ PID GRAM POSITIVE IDENTIFICATION PANEL LQL BECTON DICKINSON & CO. (SPARKS) 4240517 30382904480081

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female