BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19846556 · Received July 27, 2024

    Report

    Report Number
    3003442380-2024-17176
    Event Type
    Malfunction
    Date Received
    July 27, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 27, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1923537 - MDR 3003442380-2024-17176 - DEVICE 7 OF 10.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED 10 INFUSION SET WAS LEAKAGE AT SITE ON (B)(6) 2024. THE INFUSION SET HAS BEEN USED FOR APPROX 6-24 HOURS. THE BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF EVENTS .PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776473 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male