BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETEST® METRONIDAZOLE MZH

    MDR report key: 5616781 · Received April 28, 2016

    Report

    Report Number
    3002769706-2016-00075
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Report Date
    April 5, 2016
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    JWY
    PMA / PMN Number
    K913459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO A DISCREPANT RESULT EVENT WHILE USING THE ETEST METRONIDAZOLE WAS PERFORMED. THE CUSTOMER DID NOT RETURN THEIR STRAIN FOR TESTING AT BIOMERIEUX. QUALITY CONTROL SAMPLES WITH ATCC 25922, ATCC 29741 AND ATCC 25285 WERE RUN WITH RETAIN SAMPLES FROM FIVE (5) LOTS ETEST METRONIDAZOLE TEST KITS. THE RESULTS OF ALL TESTING WERE WITHIN SPECIFICATIONS FOR ALL SAMPLES. BASED ON THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AND THE PRODUCT IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A DISCREPANT RESULTS ASSOCIATED WITH ETEST(TM) METRONIDAZOLE MZH 256 (REFERENCE (B)(4)). THE CUSTOMER REPORTED ALWAYS GETTING LOW MINIMAL INHIBITORY CONCENTRATION (MIC) WHEN DOING CONTROLS. THE CUSTOMER IDENTIFIED THE CONTROL STRAIN AS E. COLI ATCC (B)(6). THE APPROVED SPREADING INTERVAL WAS 0.25-1 MG/L AND AN ANAEROBE PLATE WITHOUT ANTIBIOTICS WAS UTILIZED. AN INVESTIGATION INTO THE EVENT WILL BE INITIATED BY BIOMERIEUX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270238 ETEST® METRONIDAZOLE MZH ETEST® METRONIDAZOLE MZH JWY BIOMERIEUX, SA 1003007690

    Patients

    Seq Age Sex Outcome Treatment
    1