BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19881268 · Received August 1, 2024

    Report

    Report Number
    3003442380-2024-18283
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    May 28, 2024
    Report Date
    August 1, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - MDR 3003442380-2024-18283 - DEVICE 1 OF 7.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(6) EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED SEVEN INFUSION SETS LEAKAGE AT SITE EVENTS ON (B)(6) 2024 WITHIN 3 HOURS AFTER INSERTION. INFUSION SET WAS USED FOR A DAY AND A HALF. INSERTION SITE WAS ABDOMEN. THE BLOOD GLUCOSE LEVEL WAS REPORTED 150 -152 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963426 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male