BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 19673597 · Received July 4, 2024

    Report

    Report Number
    3003442380-2024-11929
    Event Type
    Malfunction
    Date Received
    July 4, 2024
    Date of Event
    May 16, 2024
    Report Date
    July 4, 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 1902245- MDR 3003442380-2024-11929- DEVICE 11 OF 14.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH 14 INFUSION SETS ADHESIVE ON (B)(6) 2024.THE INFUSION SET FELL OFF DURING USE. THE INFUSION SET WAS IN USE FOR 2-4 HOURS. THE PATIENT CONFIRMED THE SET FELL OFF WHILE DOING PHYSICAL ACTIVITY/SWEATING, SWIMMING, OR BATHING.THE BLOOD GLUCOSE LEVEL WAS 15-17 MMOL/L. RELEVANT TREATMENT FOR HIGH BLOOD GLUCOSE INCLUDED CORRECTION BOLUS VIA PUMP, MDI AND CHANGED INFUSION SET. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349031 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 33 YR Male