BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOGENE

    MDR report key: 12374693 · Received August 26, 2021

    Report

    Report Number
    1524213-2021-00001
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 26, 2021
    Report Date
    August 26, 2021
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OOI
    UDI-DI
    00840733102318
    PMA / PMN Number
    K170558
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS COMPLETING A TEST RUN UTILIZING 3 PREPARED REVOGENE GROUP A STREP TEST DEVICES AND 5 REVOGENE MOCKPIES. THE CUSTOMER REPORTED THAT THE INSTRUMENT ABORTED THE TEST RUN AFTER SMOKE APPEARED FROM THE INSTRUMENT. THE LID WAS DIFFICULT TO OPEN AND THE RETENTION RING WAS VERY WARM. THE PIES SHOWED SIGNS OF MELTING. THERE WERE NO INJURIES OR LABORATORY DAMAGE REPORTED. WHILE THERE WAS NO INJURIES OR DETERIORATION OF HEALTH REPORTED WITH THIS INCIDENT, THIS INCIDENT HAS THE POTENTIAL TO CAUSE A BURN THROUGH ACCIDENTAL CONTACT WITH THE HEATED INSTRUMENT COMPONENTS OR MELTED PIES. IMPACT OF BURNS COULD RANGE FROM MINOR SEVERITY TO SERIOUS INJURY DEPENDING ON THE LOCATION AND DURATION OF CONTACT. THE INABILITY TO COMPLETE THE TEST RUN COULD LEAD TO AN INABILITY TO PRESCRIBE NECESSARY TREATMENT. SYMPTOMS COULD PROGRESS AND THE DISEASE STATE MAY WORSEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273094 REVOGENE REVOGENE OOI MERIDIAN BIOSCIENCE INC. N/A N/A 00840733102318

    Patients

    Seq Age Sex Outcome Treatment
    1