BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19869095 · Received July 30, 2024

    Report

    Report Number
    3003442380-2024-17780
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    April 23, 2024
    Report Date
    July 31, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1926578 - MDR 3003442380-2024-17780 - DEVICE 1 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED AN ADHESIVE EVENT WHERE THREE INFUSION SETS FELL OFF ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR ONE HOUR. DEXCOM WAS USED AS AN ADHESIVE PATCH. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586586 AUTOSOFT XC UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1006922 6004838

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female