BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 19495656 · Received June 9, 2024

    Report

    Report Number
    3003442380-2024-07443
    Event Type
    Malfunction
    Date Received
    June 9, 2024
    Date of Event
    April 28, 2024
    Report Date
    June 9, 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 1883831- MDR 3003442380-2024-07443- DEVICE 3 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT THREE INFUSION SET TUBING WAS LEAKING DUE TO WHICH HYPERGLYCEMIA OCCURS AFTER 7 HOURS OF USE. HIGH BLOOD GLUCOSE LEVEL WAS DISPLAYED HIGH AND TREATED BY CORRECTION INJECTION VIA MDI. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106999 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 23 YR Male