BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ PID

    MDR report key: 24316528 · Received February 11, 2026

    Report

    Report Number
    1119779-2026-00126
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    December 17, 2025
    Report Date
    March 3, 2026
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LQL
    UDI-DI
    00382904480080
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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 5192138. THE CUSTOMER RETURNED PHOENIX GENERATED LAB REPORTS SHOWING STAPHYLOCOCCUS AUREUS AND STAPHYLOCOCCUS EPIDERMIDIS IDENTIFICATIONS FOR THE INVESTIGATION. 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. TO INVESTIGATE, PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATE S. EPIDERMIDIS POS 3644 ON A PHOENIX M50 MACHINE AND EVALUATED FOR IDENTIFICATION RESULTS. THE PANELS TESTED IDENTIFIED THEIR INOCULATED ISOLATES CORRECTLY, THIS COMPLAINT IS NOT CONFIRMED.

    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 (STAPHYLOCOCCUS EPIDERMIDIS) WAS MISIDENTIFIED AS STAPHYLOCOCCUS AUREUS OR STAPHYLOCOCCUS SAPROPHYTICUS. THE USER VERIFIED THE FINAL RESULT BY PERFORMING REPEAT TESTING USING A REFERENCE LABORATORY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ PID A PATIENT ISOLATE (STAPHYLOCOCCUS EPIDERMIDIS) WAS MISIDENTIFIED AS STAPHYLOCOCCUS AUREUS OR STAPHYLOCOCCUS SAPROPHYTICUS. THE USER VERIFIED THE FINAL RESULT BY PERFORMING REPEAT TESTING USING A REFERENCE LABORATORY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219071 BD PHOENIX¿ PID GRAM POSITIVE IDENTIFICATION PANEL LQL BECTON DICKINSON & CO. (SPARKS) 5192138 00382904480080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown