BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19835276 · Received July 26, 2024

    Report

    Report Number
    3003442380-2024-16861
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    June 2, 2024
    Report Date
    July 26, 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 1922603 - DEVICE 2 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND CONSEQUENTLY WAS HOSPITALIZED ON (B)(6) 2024. THE EVENT OF LEAKAGE OCCURED WITH 6 TUBINGS OF INFUSION SET. THE BLOOD GUCOSE LEVEL OF THE PATIENT WAS OVER 500 MG/DL. THE KETONES LEVEL WERE HIGH AND WERE LIFETHREATENING. RELEVANT TREATMENT INCLUDED INTRAVENOUS AND FLUIDS OF SALINE AND INSULIN TO TRAT HIGH BLOOD GLUCOSE. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562167 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 25 YR Female Life Threatening| H