BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREATHTEK UBT

    MDR report key: 16161261 · Received January 13, 2023

    Report

    Report Number
    1524213-2023-00001
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    January 5, 2023
    Report Date
    January 13, 2023
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OZA
    UDI-DI
    00840733101434
    PMA / PMN Number
    P100025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT COMPLETED UBT TESTING ON (B)(6) 2023 AT 8:04AM. CUSTOMER NOTED THAT WHEN LEAVING THE UBT TESTING, PATIENT HAD A HEADACHE SIMILAR TO A PAST MIGRAINE BUT HAD INDICATED THAT SHE HAD NOT HAD A MIGRAINE IN OVER A YEAR. PATIENT WENT HOME AND WAS EXPERIENCING NAUSEA, VOMITING, DIARRHEA, AND "TALKING OUT OF HER HEAD". PATIENT BEGAN VOMITING AROUND NOON (12:00PM). AT 2:00PM, SHE WAS TAKEN TO THE EMERGENCY ROOM BY HER HUSBAND WHERE SHE WAS DIAGNOSED WITH A HYPERTENSIVE EMERGENCY. IT WAS NOTED THAT A HEMORRHAGE WAS SEEN ON HER CT SCAN. CUSTOMER REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN THE AFTERNOON ON (B)(6) 2023. CUSTOMER REPORTED THAT THE DISCHARGE NOTED MENTIONED THAT THERE WERE NO ACUTE FINDINGS. WHILE THERE IS NO INDICATION THAT THE PERFORMANCE OF OR RESULTS PROVIDED BY THE BREATHTEK CAUSED OR CONTRIBUTED TO THE PATIENT'S CONDITION, MERIDIAN BIOSCIENCE HAS ELECTED TO SUBMIT AN MDR OUT OF AN EXTREME ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964764 BREATHTEK UBT BREATHTEK UBT OZA MERIDIAN BIOSCIENCE INC. 01 383K05S 00840733101434

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Other