BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETEST FLUCONAZOLE FL 256 WW S30

    MDR report key: 11793463 · Received May 7, 2021

    Report

    Report Number
    9615754-2021-00150
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Report Date
    May 7, 2021
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    NGZ
    PMA / PMN Number
    K040560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE SUSCEPTIBLE FLUCONAZOLE RESULTS FOR CANDIDA GLABRATA IN ASSOCIATION WITH THE ETEST® FLUCONAZOLE FL 256 WW S30 (REF 412350, LOT 1008297750). THE CUSTOMER REPORTED OBSERVING THE SAME ISSUE WITH EIGHT (8) PATIENT SAMPLES. THE CUSTOMER PERFORMED ANALYSIS WITH BOTH BROTH MICRODILUTION (BMD) AND ETEST® FLUCONAZOLE FL 256 WW S30. BMD = FLUCONAZOLE RESISTANT ETEST = FLUCONAZOLE SUSCEPTIBLE THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. NOTE: ETEST® FLUCONAZOLE FL 256 WW S30 (REF 412350) IS NOT REGISTERED FOR USE IN THE UNITED STATES. HOWEVER A SIMILAR PRODUCT, ETEST® FLUCONAZOLE FL 256 US S30 (REF 412349), IS REGISTERED FOR USE IN THE UNITED STATES (K040560).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687426 ETEST FLUCONAZOLE FL 256 WW S30 ETEST® FLUCONAZOLE FL 256 WW S30 NGZ BIOMERIEUX, SA 1008297750

    Patients

    Seq Age Sex Outcome Treatment
    1