BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREATHTEK UBT

    MDR report key: 13607465 · Received February 25, 2022

    Report

    Report Number
    1524213-2022-00002
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    January 27, 2022
    Report Date
    February 25, 2022
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OZA
    UDI-DI
    00084073310134
    PMA / PMN Number
    P100025
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    MERIDIAN BIOSCIENCE INC. HAS DETERMINED THAT AN MDR IS NEEDED AS THE CUSTOMER INGESTED THE PRANACTIN CTRIC SOLUTION WITHOUT WAITING THE REQUIRED 24 HOURS AS DICTATED BY PRODUCT LABELING. ALTHOUGH THERE WERE NO REPORTED ADVERSE EXPERIENCES, MERIDIAN IS SUBMITTING THIS REPORT OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    THE CUSTOMER HAD EXECUTED THE BREATHTEK UBT TEST AS PART OF AN INSTRUMENT TROUBLESHOOTING ACTIVITY. THE CUSTOMER STATED THAT THEY FOLLOWED THE PACKAGE INSERT INSTRUCTIONS FOR PERFORMING THE TEST. THIS INCLUDES ALL THAT IS REQUIRED PRIOR TO INGESTING THE SOLUTION, INGESTION, AND THEN BREATHING INTO THE BAGS. THE SAME PERSON REPEATED TESTING FOUR (4) HOURS LATER. THE CUSTOMER FAILED TO ADHERE TO THE INSTRUCTIONS INDICATING IF REPEAT TESTING IS NEEDED, THE BREATHTEK UBT CAN BE ADMINISTERED AGAIN THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210122 BREATHTEK UBT BREATHTEK UBT OZA MERIDIAN BIOSCIENCE INC. 359K05S 00084073310134

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown