BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19495183 · Received June 9, 2024

    Report

    Report Number
    3003442380-2024-07361
    Event Type
    Malfunction
    Date Received
    June 9, 2024
    Date of Event
    February 1, 2024
    Report Date
    June 9, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026001
    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 1883881- MDR 3003442380-2024-07361- DEVICE 3 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET FELL OFF DURING USE IN FEBRUARY ( ONE EVENT), MARCH ( THREE EVENTS),APRIL (TWO EVENT). THE BLOOD GLUCOSE LEVEL OF THE PATIENT AT THE TIME OF EVENT RANGED BETWEEN 170 TO 180 MG/DL. THE ISSUE OCCURRED WITH SIX SIMILAR TYPES OF INFUSION SET USED FOR ONE OR TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106909 AUTOSOFT XC INSET I 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1010900 UNKNOWN 05705244026001

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male