BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19605005 · Received June 25, 2024

    Report

    Report Number
    3003442380-2024-10167
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    January 1, 2024
    Report Date
    June 25, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    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 1896206 - DEVICE 8 OF 20.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT EXPERIENCED THAT INFUSION SET FELL OFF DURING USE. ALSO, REPORTED THAT TWENTY INFUSION SETS WERE AFFECTED. THE FIRST ONE TO SEVENTEEN EVENTS OCCURRED IN THE START OF THE YEAR AND THEN ON (B)(6) 2024, (B)(6) 2024, (B)(6) 2024 RESPECTIVELY. THE INFUSION SET WAS LASTED FOR TWO TO THREE DAYS, THOUGH THEY SOMETIMES LAST UNTIL HE'S ABOUT TO CHANGE THEM. ALSO, THE AREA OF INSERTION WAS CLEANED AND AIR-DRIED. THE PATIENT REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481876 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 UNKNOWN 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male