BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALETHIA

    MDR report key: 23605410 · Received November 20, 2025

    Report

    Report Number
    1524213-2025-00006
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 20, 2025
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OOI
    UDI-DI
    00840733101663
    PMA / PMN Number
    K100818
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT IS UNAVAILABLE FOR FURTHER EVALUATION AS THE CUSTOMER HAD CONFIRMED TO DISCARD THE INSTRUMENT AND ITS COMPONENTS IN ACCORDANCE WITH APPLICABLE POLICIES, LOCAL ENVIRONMENTAL REGULATIONS, AND SAFETY REQUIREMENTS.

    Description of Event or Problem · 0

    ON (B)(6) 2025, MERIDIAN BIOSCIENCE INC. WAS FORWARDED INFORMATION RELATED TO AN INCIDENT INVOLVING A CUSTOMER LOCATED IN AUSTRALIA. CUSTOMER HAD TURNED THE ALETHIA INSTRUMENT OFF TO COMPLETE THE REQUIRED CLEANING PROCEDURE. THE UNIT WAS TURNED BACK ON TO RESUME USE. DURING NORMAL USE, AFTER THE UNIT IS TURNED ON, THE BLOCKS AUTOMATICALLY START TO WARM UP TO OPERATING TEMPERATURE. TEST RUNS ARE UNABLE TO BE INITIATED UNTIL THE COMPLETION OF THIS WARMUP PERIOD. DURING THIS WARMUP PERIOD, IT WAS IDENTIFIED THAT ONLY BLOCK A WAS WARMING UP. SHORTLY AFTER, THE SCREEN WENT OFF, THERE WAS A 'POP SOUND' AND THEN A SMELL OF ELECTRICAL BURN FROM AC ADAPTOR ON THE POWER CORD. THE CUSTOMER SWITCHED THE INSTRUMENT OFF, WAITED 15-20 MINUTES, AND TRIED AGAIN, BUT THE SMELL PERSISTED SO THEY DECIDED TO FULLY SHUT IT DOWN AND NOT TURN IT ON AGAIN. THE CUSTOMER THEN WITHDREW THE INSTRUMENT FROM OPERATIONAL USE. WHILE THERE WERE NO REPORTED CLAIMS OF SERIOUS INJURY OR HARM 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
    293567 ALETHIA ALETHIA OOI MERIDIAN BIOSCIENCE INC. 00840733101663

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown