BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19678684 · Received July 5, 2024

    Report

    Report Number
    3003442380-2024-12145
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    May 9, 2024
    Report Date
    July 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244014541
    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 1904738- MDR 3003442380-2024-12145- DEVICE 4 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH 4 INFUSION SETS ADHESIVE. THE FIRST EVENT OCCURED ON (B)(6) 2024 AND 2ND 3RD ON (B)(6) 2024 OTHER BEING UNKNOWN THE PATIENT REPORTED INFUSION SET FELL OFF DURING USE. MOST OF THE SETS NEVER STUCK AND ONE WAS IN USE FOR AN HOUR. THE PATIENT CONFIRMED THE SET FELL OFF WHILE DOING PHYSICAL ACTIVITY/SWEATING, SWIMMING, OR BATHING. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282083 AUTOSOFT 90 INSET II 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1000281 5381142 05705244014541

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male