BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19846533 · Received July 27, 2024

    Report

    Report Number
    3003442380-2024-17172
    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 3003442380-2024-17172 - DEVICE 3 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
    1775432 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