BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19516716 · Received June 11, 2024

    Report

    Report Number
    3003442380-2024-07737
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    May 6, 2024
    Report Date
    June 11, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016712
    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 1884991.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SET WAS FELL OFF DURING USE EVENT FROM 20-APR-2024 TO 06-MAY-2024. THE INFUSION SET WAS IN USE FOR 24-30 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374128 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 UNKNOWN 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female