BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFTÂ XC

    MDR report key: 19937733 · Received August 8, 2024

    Report

    Report Number
    3003442380-2024-19883
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    June 16, 2024
    Report Date
    July 9, 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 1934254 - MDR 3003442380-2024-19883 - DEVICE 1 OF 2.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2022, THE PATIENT FACED THAT 3-INFUSION SET FELL OFF DURING USE. CUSTOMER WAS DOING PHYSICAL ACTIVITY/SWEATING, SWIMMING, OR BATHING AT THE TIME THE SET FELL OFF. 1ST INFUSION SET HAS BEEN FOR APPROXIMATELY 2 DAYS, 2ND SET FOR 5 MINS, 3RD SET FOR 2 HOURS . TAP WAS APPLIED OVER THE INFUSION SET. INSERTION AREA WAS CLEANED, AIR-DRIED AND FREE FROM HAIR. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531823 AUTOSOFTÂ XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6004417 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male