BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETEST® VORICONAZOLE

    MDR report key: 6086722 · Received November 8, 2016

    Report

    Report Number
    3002769706-2016-00466
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Report Date
    January 13, 2020
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    JWY
    PMA / PMN Number
    K082534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: THIS SUPPLEMENT REPORT IS BEING SUBMITTED FOLLOWING FDA NOTIFICATION OF A MISSING REPORT. THE INITIAL SUPPLEMENT REPORT WAS INADVERTENTLY LABELED WITH AN INCORRECT REPORT NUMBER "YEAR" (I.E. 3002769706-2017-00466), AND WAS THEREFORE NOT LINKED APPROPRIATELY TO THE INITIAL REPORT. THE REPORT NUMBER SHOULD HAVE BEEN 3002769706-2016-00466. A BIOMÉRIEUX INVESTIGATION WAS CONDUCTED FOR A DISCREPANT RESULT (OUT-OF-RANGE-LOW) FOR CANDIDA ALBICANS, ATCC® 90028, ASSOCIATED WITH ETEST® VORICONAZOLE VO 32 WW F100. THE INVESTIGATION INVOLVED TESTING THE ETEST® VORICONAZOLE VO 32 (LOT 1003390050) CUSTOMER STRIPS, RETAINED STRIP SAMPLES, AND A DIFFERENT LOT AS REFERENCE, WITH 3 ATCC STAINS (ATCC 90028 - ATCC 6258 - ATCC 22019). THE ISSUE OBSERVED BY THE CUSTOMER WITH THE QUALITY CONTROL STRAINS WAS NOT REPRODUCED. THE CUSTOMER STATED THAT INSTEAD OF STREAKING THE PLATES, THEY "FLOW" THE PLATES BEFORE THEY APPLY THE ETEST®. INOCULATION BY FLOATING IS NOT THE RECOMMENDED PROCEDURE STATED IN THE INSTRUCTIONS FOR USE (PACKAGE INSERT) AND IT'S NECESSARY FOR ANTIFUNGALS TO SWAB TWICE. THE INVESTIGATION CONCLUDED THE ETEST® VORICONAZOLE VO 32 WW F100 IS PERFORMING AS INTENDED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A DISCREPANT RESULT (OUT-OF-RANGE-LOW) FOR CANDIDA ALBICANS, ATCC® 90028, ASSOCIATED WITH ETEST® VORICONAZOLE VO 32 WW F100. THE CUSTOMER HAD TESTED TWO BATCHES OF VORICONAZOLE IN WHICH BOTH GAVE LOW RESULTS. CUSTOMER STATED THAT INSTEAD OF STREAKING THE PLATES, THEY "FLOW" THE PLATES BEFORE THEY APPLY THE ETEST®. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE NEQAS SURVEY SAMPLE. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736758 ETEST® VORICONAZOLE ETEST® VORICONAZOLE JWY BIOMERIEUX, SA 1004139440

    Patients

    Seq Age Sex Outcome Treatment
    1