BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19518316 · Received June 12, 2024

    Report

    Report Number
    3003442380-2024-07572
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    April 28, 2024
    Report Date
    June 12, 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 1885171 - MDR 3003442380-2024-07572- 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 3 INFUSIONS SET FELL OFF DURING USE ON EVENT ON (B)(6) 2024. TAPE WAS APPLIED OVER THE INFUSION SET. INFUSION SET HAS BEEN USED FOR TWO DAYS. INSERTION AREA WAS CLEANED, AIR-DRIED AND FREE FROM HAIR. CUSTOMER WAS DOING PHYSICAL ACTIVITY/SWEATING, SWIMMING, OR BATHING AT THE TIME THE SET FELL OFF CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188670 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 6002432 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male