BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19583732 · Received June 21, 2024

    Report

    Report Number
    3003442380-2024-09452
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 11, 2024
    Report Date
    June 21, 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 1894413- MDR 3003442380-2024-09452- DEVICE 1 OF 2

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SETS FELL OFF DURING USE EVENTS ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 2 DAYS. THE BLOOD GLUCOSE LEVEL WAS 100-280 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281202 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 17 YR Male