BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 19901255 · Received August 3, 2024

    Report

    Report Number
    3003442380-2024-18762
    Event Type
    Malfunction
    Date Received
    August 3, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018365
    PMA / PMN Number
    K061374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1931661- MDR 3003442380-2024-18762 - DEVICE 6 OF 7.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH 7 INFUSION SETS ADHESIVE FROM (B)(6) 2024 TO (B)(6) 2024. THE INFUSION SET FELL OFF AFTER BEING IN USE FOR 24-36 HOURS WHILE DOING PHYSICAL ACTIVITY/SWEATING, SWIMMING, OR BATHING. THE ISSUE WAS RESOLVED BY REPLACING INFUSION SET AND RESUMING INSULIN. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384990 AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002825 UNKNOWN 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male