BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19736671 · Received July 13, 2024

    Report

    Report Number
    3003442380-2024-13972
    Event Type
    Malfunction
    Date Received
    July 13, 2024
    Date of Event
    May 31, 2024
    Report Date
    July 13, 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 1911396 - MDR 3003442380-2024-13972- DEVICE 1 OF 2

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED INFUSION SET FELL OFF EVENT ON (B)(6)2024. THE INFUSION SET WAS IN USE FOR LESS THAN 2 HOURS. THE BLOOD GLUCOSE LEVEL WAS 121-160 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862300 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 52 YR Female