BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOGENE

    MDR report key: 22331330 · Received June 25, 2025

    Report

    Report Number
    1524213-2025-00003
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    September 14, 2020
    Report Date
    June 9, 2025
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OOI
    UDI-DI
    00840733102318
    PMA / PMN Number
    K243922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON SEPTEMBER 14, 2020, CUSTOMER CALLED TECHNICAL SUPPORT (TS) AND REPORTED DURING A RUN ON A REVOGENE INSTRUMENT THEY SMELLED A BURNING ODOR. CUSTOMER STATED THAT THEY IMMEDIATELY ABORTED THE RUN ON THE REVOGENE INSTRUMENT. TS INFORMED THEM THAT A BURNING SMELL IS TYPICALLY A PIE RUBBING AGAINST THE INSIDE OF THE REVOGENE INSTRUMENT BECAUSE IT ISN'T SEATED PROPERLY. REVOGENE INSTRUMENT WAS ON A CABINET WHICH MAY NOT BE STABLE ENOUGH FOR THE REVOGENE INSTRUMENT. THE REVOGENE INSTRUMENT WAS MOVED TO A COUNTER AND ANOTHER INSTRUMENT MOVED TO THE CABINET. CUSTOMER IS SATISFIED WITH TS ASSISTANCE. IT IS A KNOWN FAILURE MODE THAT IMPROPERLY SETTING PIES IN THE ROTOR CAN LEAD TO A "BLOCKED ROTOR" AND LEFT UNATTENDED CAN RESULT IN THE SMELL OF HEATED PLASTIC; HOWEVER, THE INSTRUMENT WILL SHUT DOWN IF THE ROTOR BECOMES BLOCKED. THE PRODUCT LABELING DESCRIBES THE IMPORTANCE OF SEATING PIES IN THE ROTOR PROPERLY. THIS COMPLAINT WAS FOUND AS PART OF A REVIEW FOR MDR 1524213-2024-00001 AND AFTER CAREFUL REVIEW, MERIDIAN HAS ELECTED TO REPORT OUT OF AN EXTREME ABUNDANCE OF CAUTION. THERE WERE NO REPORTED CLAIMS OF SERIOUS INJURY OR HARM AS A RESULT OF THE BURNING SMELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2588244 REVOGENE REVOGENE OOI MERIDIAN BIOSCIENCE INC. 00840733102318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other