BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ YEAST ID

    MDR report key: 13699122 · Received March 8, 2022

    Report

    Report Number
    1119779-2022-00391
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 12, 2022
    Report Date
    June 26, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JXB
    UDI-DI
    30382904483167
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H.6# THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR MISIDENTIFICATION OF CANDIDA AURIS AS CANDIDA TROPICALIS WHEN USING PHOENIX PANEL YID ((B)(4)) BATCH NUMBER 1201556. THE CUSTOMER DID NOT RETURN LAB REPORTS, PANELS, OR ISOLATES FOR INVESTIGATION. CANDIDA AURIS IS NOT LISTED ON EITHER TAXA LIST FOR THE PHOENIX 100 OR PHOENIX M50 INSTRUMENT. 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 THE COMPLAINT 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. PER BALTRMPHXIDASTAPH REV 10 VERSION H, ID 6.0-6.11, INDICATES THE POTENTIAL RISK OF A MIS-IDENTIFICATION WAS ASSESSED AS S4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHOENIX¿ YEAST ID MISIDENTIFIED THE ORGANISM AS CANDIDA TROPICALIS INSTEAD OF CANDIDA AURIS. THIS OCCURRED 25 SEPARATE TIMES DURING USE. CONFIRMATORY TESTING WAS DONE ON ANOTHER INSTRUMENT, WHICH IDENTIFIED THE CORRECT ORGANISM. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "YID PANELS ARE GIVEN WRONG IDENTIFICATION LIKE CANDIDA TROPICALIS INSTEAD OF CANDIDA AURIS BUT ON DIFFERENT INSTRUMENT IT HAS IDENTIFIED CORRECT ORGANSIM."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHOENIX¿ YEAST ID MISIDENTIFIED THE ORGANISM AS CANDIDA TROPICALIS INSTEAD OF CANDIDA AURIS. THIS OCCURRED 25 SEPARATE TIMES DURING USE. CONFIRMATORY TESTING WAS DONE ON ANOTHER INSTRUMENT, WHICH IDENTIFIED THE CORRECT ORGANISM. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "YID PANELS ARE GIVEN WRONG IDENTIFICATION LIKE CANDIDA TROPICALIS INSTEAD OF CANDIDA AURIS BUT ON DIFFERENT INSTRUMENT IT HAS IDENTIFIED CORRECT ORGANSIM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168130 BD PHOENIX¿ YEAST ID KIT, IDENTIFICATION, YEAST JXB BECTON, DICKINSON & CO. (SPARKS) 448316 1201556 30382904483167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown