BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20448924 · Received October 15, 2024

    Report

    Report Number
    3003442380-2024-28360
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 18, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026032
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 2011715 - MDR 3003442380-2024-28360 - DEVICE 3 OF 3.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SET KINKED CANNULA EVENTS. THE SET WAS IN USE FOR 3-24 HOURS. EVENT OCCURRED AFTER THREE HOURS OF INSERTION. INSERTION SITE WAS AT ABDOMEN. BLOOD GLUCOSE LEVELS WERE REPORTED TO BE HIGHER THAN 500 MG/DL. PATIENT TOOK CORRECTION BOLUS VIA PUMP TO ADDRESS THE EVENT, REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35866 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6005870 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female