BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOGENE

    MDR report key: 23480262 · Received November 5, 2025

    Report

    Report Number
    1524213-2025-00004
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 5, 2025
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OOI
    UDI-DI
    00840733102318
    PMA / PMN Number
    K243922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PRELIMINARY INVESTIGATION WAS COMPLETED BY THE INSTRUMENT'S CONTRACT MANUFACTURER, MERIDIAN BIOSCIENCE CANADA. THIS INVESTIGATION CONFIRMED THAT THE INSTRUMENT'S COOLING PERIOD WAS FUNCTIONING PROPERLY THUS REDUCING ANY RISKS ASSOCIATED WITH INCIDENTAL CONTACT WITH HEATED COMPONENTS BY THE USER.

    Description of Event or Problem · 0

    ON (B)(6) 2025, MERIDIAN BIOSCIENCE INC. TECHNICAL SERVICE DEPARTMENT RECEIVED A CALL FROM A CUSTOMER WHO REPORTED A FULL RUN OF INDETERMINATE RESULTS OBTAINED DURING TESTING WITH THE REVOGENE GROUP A STREP ASSAY. CUSTOMER ALSO REPORTED A BURNING SMELL DURING THE RUN. WHEN THE RUN WAS COMPLETED, THE CUSTOMER OBSERVED THAT THE MICROFLUIDIC PIES WERE MELTED. CUSTOMER HAD THEIR CLINICAL ENGINEERING DEPARTMENT CHECK THE OUTLET AND THE CIRCUIT THE REVOGENE WAS PLUGGED INTO AND EVERYTHING CHECKED OUT OK. CUSTOMER DID NOT OBSERVE ANY VISIBLE DAMAGE TO THE INSTRUMENT OTHER THAN THE MELTED PIES. WHILE THERE WERE NO REPORTED CLAIMS OF SERIOUS INJURY OR HARM WERE REPORTED, MERIDIAN HAS ELECTED TO SUBMIT THIS REPORT OUT OF AN EXTREME ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2677203 REVOGENE REVOGENE OOI MERIDIAN BIOSCIENCE INC. 00840733102318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown