BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20461115 · Received October 16, 2024

    Report

    Report Number
    3003442380-2024-28441
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 8, 2024
    Report Date
    September 18, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022386
    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 2011695, DEVICE 3 OF 8.

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED EIGHT INFUSION SET CANNULA KINKED EVENTS BETWEEN 08-SEP-2024 AND 14-SEP-2024. SOME EVENTS OCCURRED WITHIN 3 OR MORE HOURS OF INSERTION, WHILE OTHERS OCCURRED IN 5-6 HOURS. THE INSERTION SITE WAS ON THE ABDOMEN. THE BLOOD GLUCOSE LEVEL WAS 500 MG/DL WITH THE PRESENCE OF KETONES AT THE TIME OF THE EVENTS; THEREFORE, IT WAS TREATED WITH A CORRECTION INJECTION VIA MULTIPLE DAILY INJECTIONS (MDI). COMPANY DO NOT SEE KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353458 AUTOSOFT XC UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1006922 6007168 05705244022386

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female