BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19881277 · Received August 1, 2024

    Report

    Report Number
    3003442380-2024-18289
    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 3003442380-2024-18289 - DEVICE 7 OF 7

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). 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 AND (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
    2025154 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male