BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOGENE

    MDR report key: 15258669 · Received August 19, 2022

    Report

    Report Number
    1524213-2022-00007
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Date of Event
    July 5, 2022
    Report Date
    August 19, 2022
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OOI
    UDI-DI
    00840733102318
    PMA / PMN Number
    K170558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MERIDIAN BIOSCIENCE CANADA, THE INSTRUMENT'S CONTRACT MANUFACTURER, COMPLETED A REVIEW OF THE INSTRUMENT'S RAW DATA AND SYSTEM EVENT REPORTS. DURING THIS REVIEW, IT WAS IDENTIFIED THAT THE INSTRUMENT ABORTED RUNS ON (B)(6) 2022, (B)(6) 2022, AND (B)(6) 2022, AFTER ERROR CODE "057-003" WAS PRESENTED. AN ADDITIONAL ABORTED RUN OCCURRED ON (B)(6) 2022, AFTER ERROR CODE "058-003" WAS PRESENTED. THESE ERROR CODES ("057-003" AND "058-003") ARE PRESENTED WHEN THE EXCITATION RESULT VALUE IS UNDER A DEFINED THRESHOLD FOR A SPECIFIC CHANNEL. THESE ERROR CODES ARE INDICATIVE OF A MALFUNCTIONING PHOTOMULTIPLIER TUBE. WHEN ERROR CODES 057 AND 058 OCCURS, THE REVOGENE IS AT THE END OF THE ANNEALING STEP (NO MATTER WHICH CYCLE IT HAPPENS). AT THAT MOMENT, THE INSTRUMENT IS AROUND 55-60°C.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE INSTRUMENT BEGAN ABORTING RUNS. UPON THE FIRST ABORTED PATIENT RUN (ON (B)(6) 2022), THE CUSTOMER NOTED THAT THE INSTRUMENT WAS "SUPER-HOT" INSIDE OF THE LID. THE CUSTOMER THEN EXPERIENCED AN ABORTED PATIENT RUN ON (B)(6) 2022 AND THE NOTED THE INSTRUMENT WAS "UNUSUALLY WARM" ON THE INSIDE OF THE LID. THE INSTRUMENT ALSO ABORTED A PATIENT RUN ON (B)(6) 2022. MERIDIAN BECAME AWARE OF THIS EVENT ON (B)(6) 2022. WHILE NO CLAIMS OF INJURY OR BURNS WERE REPORTED WITH EACH OCCURRENCE, MERIDIAN HAS ELECTED TO SUBMIT THIS REPORT OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994239 REVOGENE REVOGENE OOI MERIDIAN BIOSCIENCE INC. 610210 00840733102318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown