BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOGENE

    MDR report key: 13386478 · Received January 28, 2022

    Report

    Report Number
    1524213-2022-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    November 5, 2021
    Report Date
    January 27, 2022
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OOI
    PMA / PMN Number
    K170558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MERIDIAN BIOSCIENCE INC. HAS IDENTIFIED THAT THE PHOTOMULTIPLIER TUBE (HERE FORWARD REFERRED TO AS "PMT"), A KEY COMPONENT IN THE REVOGENE INSTRUMENT'S OPTICAL SYSTEM, MAY HAVE COMPROMISED FUNCTIONALITY IN SOME INSTRUMENTS. MERIDIAN HAS RECEIVED REPORTS ASSOCIATED WITH AN INCREASE IN FALSE-POSITIVE AND INDETERMINATE RESULTS OBTAINED ON REVOGENE INSTRUMENTS. MERIDIAN IS CURRENTLY INVESTIGATING THE ISSUE. IN (B)(6) 2021, MERIDIAN RECEIVED A WRITTEN REPORT FROM THE PMT MANUFACTURER REGARDING THE PMT FAILURE AND HAS IDENTIFIED THE INCREASED RATE OF FALSE-POSITIVE AND INDETERMINATE RESULTS TO BE ASSOCIATED WITH A CRACK IN THE PMT SOLDERING JOINT. MERIDIAN HAS DEVELOPED A SOFTWARE UPDATE TO ADDRESS THE ISSUE AND IS PLANNING TO RELEASE THIS UPDATE TO FACILITATE IDENTIFICATION OF INSTRUMENTS AT RISK. MERIDIAN IS CONTINUING TO INVESTIGATE THE CAUSE OF CRACKED SOLDERING JOINTS. IN THE MEANTIME, MERIDIAN IS SUBMITTING THIS MEDICAL DEVICE REPORT OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117917 REVOGENE REVOGENE OOI MERIDIAN BIOSCIENCE INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown