BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETEST ® METRONIDAZOLE (MZH 256) US

    MDR report key: 5103812 · Received September 25, 2015

    Report

    Report Number
    3002769706-2015-00102
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Report Date
    August 21, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JWY
    PMA / PMN Number
    K913459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. TESTING OF BACTEROIDES THETAIOTAOMICRON ATCC® 29741 TM AND BACTEROIDES FRAGILIS ATCC® 25285 TM PROVIDED THE EXPECTED RESULT OF 0.5-2 WITH ETEST® METRONIDAZOLE. THE CUSTOMER COMPLAINT INDICATED RESULT DETERMINATION AFTER ONLY 24 HOURS OF INCUBATION. INTERNAL TESTING RESULTS WERE CONFIRMED AFTER 48 HOURS OF INCUBATION AS INSTRUCTED IN THE ETEST® APPLICATION GUIDE. ETEST® METRONIDAZOLE IS PERFORMING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A LONG STANDING ISSUES WITH ETEST® METRONIDAZOLE BEING IN LOW RANGE LIMITS WITH B. THETAIOTAOMICRON ATCC 29741, MIC 0.25, EXPECTED RESULTS 0.5-2. CUSTOMER ALSO STATES STRAIN BACTEROIDES FRAGILIS ATCC® 25285 ALWAYS RUNS ON THE LOW END (0.25 OR SLIGHTLY UNDER). CUSTOMER HAS RETESTED SAMPLES WITH CONSISTENTLY LOW RANGE RESULTS. CUSTOMER DID NOT REPORT ANY LATE RESULTS OR INCORRECT THERAPY TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637039 ETEST ® METRONIDAZOLE (MZH 256) US ETEST ® METRONIDAZOLE (MZH 256) US JWY BIOMERIEUX SA 1003149820

    Patients

    Seq Age Sex Outcome Treatment
    1