BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOGENE

    MDR report key: 14434250 · Received May 19, 2022

    Report

    Report Number
    1524213-2022-00005
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 18, 2022
    Report Date
    May 18, 2022
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OOI
    UDI-DI
    00840733102318
    PMA / PMN Number
    K170558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER WAS EXECUTING A TEST RUN WITH THE REVOGENE INSTRUMENT, CATALOG 610210. THE RUN WAS ABORTED AFTER ERROR CODE 037-014 WAS RECEIVED. THE CUSTOMER REPORTED THAT AFTER THE ABORTED RUN, THE INSTRUMENT WAS VERY WARM. WHILE THERE WERE NO REPORTED INJURIES OR BURNS ASSOCIATED WITH THIS EVENT, MERIDIAN BIOSCIENCE INC. HAS ELECTED TO SUBMIT THIS MDR OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186136 REVOGENE REVOGENE OOI MERIDIAN BIOSCIENCE INC. 610210 00840733102318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown