BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ YEAST ID

    MDR report key: 22337535 · Received June 26, 2025

    Report

    Report Number
    1119779-2025-00600
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    May 25, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JXB
    UDI-DI
    30382904483167
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR MISIDENTIFICATION OF TRICHOSPORON INKIN AND CRYPTOCOCCUS GATTII WHEN USING PHOENIX PANEL YEAST ID (CATALOG NUMBER 448316) BATCH NUMBER 4213948. CUSTOMER RETURNED PHOENIX GENERATED LAB REPORTS WERE PROVIDED FOR THE INVESTIGATION. THE LAB REPORTS SHOW VARIOUS IDENTIFICATIONS WHEN USING THE COMPLAINT BATCH. IT IS TO BE NOTED THAT BD DOES NOT HAVE CLAIMS FOR C. GATTI AND ONLY HAS CLAIMS FOR T. INKIN WHEN USING SAB AGAR. TO INVESTIGATE, PANELS OF THE COMPLAINT BATCH AND CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE TESTED USING IN HOUSE ISOLATE T. INKIN YST 1008 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. AS NO TRENDS WERE IDENTIFIED, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ YEAST ID A PATIENT ISOLATE (CRYPTOCOCCUS GATTII) WAS MISIDENTIFIED AS CRYPTOCOCCUS NEOFORMANS. THE FINAL RESULT WAS VERIFIED USING MALDI. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX¿ YEAST ID A PATIENT ISOLATE (CRYPTOCOCCUS GATTII) WAS MISIDENTIFIED AS CRYPTOCOCCUS NEOFORMANS. THE FINAL RESULT WAS VERIFIED USING MALDI. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793078 BD PHOENIX¿ YEAST ID KIT, IDENTIFICATION, YEAST JXB BECTON DICKINSON & CO. (SPARKS) 4213948 30382904483167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown