BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19921049 · Received August 6, 2024

    Report

    Report Number
    3003442380-2024-19107
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    June 14, 2024
    Report Date
    July 8, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 1933253 - MDR 3003442380-2024-19107- DEVICE 1 OF 6.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 14-JUN-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET FELL OFF DURING USE. THE INFUSION SET WAS IN USE FROM 4 HOURS TO 2 DAYS. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647421 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 UNKNOWN 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male