BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOGENE

    MDR report key: 12632718 · Received October 14, 2021

    Report

    Report Number
    1524213-2021-00002
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 14, 2021
    Report Date
    November 8, 2021
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OOI
    UDI-DI
    00840733102318
    PMA / PMN Number
    K170558
    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

    THIS IS A FOLLOW UP REPORT MADE AT THE REQUEST OF THE AGENCY. THE INITIAL REPORT FOR MDR# 1524213-2021-00002 WAS SUBMITTED BY MERIDIAN BIOSCIENCE INC. ON OCTOBER 14, 2021. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS EVENT WAS COMPLETED. THE ROOT CAUSE OF THIS EVENT IS ATTRIBUTED TO A DEFECTIVE PCR HEATING MODULE, SPECIFICALLY THE END OF THE INTERNAL COILED WIRE WAS TURNED INSIDE-OUT. AS A CORRECTIVE ACTION, ADDITIONAL VERIFICATIONS OF THE PART AND OF THE DIFFERENT ASSEMBLY STEPS ARE TO BE IMPLEMENTED. H11: ADDITIONAL DETAILS ON EVENT DESCRIPTION: AFTER INITIATION OF THE SELF-TEST, THE INSTRUMENT BECAME VERY HOT AND THERE WAS A BURNT PLASTIC SMELL COMING FROM THE INSTRUMENT. THE INSTRUMENT WAS IMMEDIATELY TURNED OFF. THE FOLLOWING DAY, AN ADDITIONAL SELF-TEST WAS INITIATED. ABOUT ONE MINUTE INTO THIS SELF-TEST SMOKE BEGAN TO COME OUT OF THE BOTTOM OF THE INSTRUMENT. UPON REMOVAL OF THE MOCK PIES, IT WAS NOTED THAT THE INSTRUMENT WAS EXTREMELY HOT TO THE TOUCH. THERE WAS NO VISIBLE DAMAGE TO THE MOCK PIE OR INSTRUMENT. THIS EVENT OCCURRED DURING INSTRUMENT INSTALLATION AT A CUSTOMER SITE. THERE WERE NO FALSE, DISCREPANT, OR QUESTIONABLE RESULTS REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    ON (B)(6) 2021, A MERIDIAN TECHNICAL SERVICE REPRESENTATIVE WAS AT THE CUSTOMER SITE ASSISTING WITH INSTRUMENT INSTALLATION. DURING INSTALLATION, A SELF-TEST WAS INITIATED. CONTINUED ON PAGE 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533545 REVOGENE REVOGENE OOI MERIDIAN BIOSCIENCE INC. 610210 00840733102318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown