BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ YEAST ID

    MDR report key: 15229489 · Received August 15, 2022

    Report

    Report Number
    1119779-2022-01110
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 2, 2022
    Report Date
    January 9, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JXB
    UDI-DI
    30382904483167
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 INVESTIGATION SUMMARY: THIS COMPLAINT IS NOT CONFIRMED. THIS COMPLAINT IS FOR MISIDENTIFICATION OF C. KRUSEI AS P.WICKERHAMII WHEN USING PHOENIX PANEL YID (448316) BATCH NUMBER 1201556. THE COMPLAINT BATCH WAS NOT AVAILABLE FOR INVESTIGATION DUE TO THE BATCH BEING EXPIRED AT THE TIME OF THE INVESTIGATION AND IS BEYOND OUR STABILITY TIMEFRAME. AS A RESULT, THIS COMPLAINT IS NOT CONFIRMED FOR PERFORMANCE. A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. A REVIEW OF COMPLAINTS REVEALED ONE ADDITIONAL COMPLAINT 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. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ YEAST ID THE CUSTOMER RECEIVED DISCREPANT RESULTS BETWEEN TWO INSTRUMENTS. CONFIRMATORY TESTS DETERMINED THAT MISIDENTIFICATION HAD OCCURRED. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER USE YEAST ID PANEL FOR YEAST IDENTIFICATION. THE PANEL RESULT FROM PHOENIX 100 IS C. KRUSEI, AND THE RESULT FROM PHOENIX M50 IS P. WICKERHAMII. THE CUSTOMER RECHECKED THE RESULT WITH MALDI-TOF, THE FINAL ID IS C. KRUSEI."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHOENIX¿ YEAST ID THE CUSTOMER RECEIVED DISCREPANT RESULTS BETWEEN TWO INSTRUMENTS. CONFIRMATORY TESTS DETERMINED THAT MISIDENTIFICATION HAD OCCURRED. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER USE YEAST ID PANEL FOR YEAST IDENTIFICATION. THE PANEL RESULT FROM PHOENIX 100 IS C. KRUSEI, AND THE RESULT FROM PHOENIX M50 IS P. WICKERHAMII. THE CUSTOMER RECHECKED THE RESULT WITH MALDI-TOF, THE FINAL ID IS C. KRUSEI.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2134370 BD PHOENIX¿ YEAST ID KIT, IDENTIFICATION, YEAST JXB BECTON, DICKINSON & CO. (SPARKS) 448316 1201556 30382904483167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown