BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 20106512 · Received August 30, 2024

    Report

    Report Number
    3003442380-2024-23444
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    July 21, 2024
    Report Date
    August 12, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1954743 - DEVICE 1 OF 2.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED SIMILAR EVENTS OF BENT CANNULA WITH TWO INFUSION SETS AFTER BEING USED FOR HALF A DAY. PATIENT NOTICED SYMPTOMS 3 OR MORE HOURS AFTER INSERTION. THE SITE OF INSERTION WAS ABDOMEN AND WAS REGULARLY ROTATED. THAT LED TO HIGH BLOOD GLUCOSE AND PATIENT TOOK A CORRECTION BOLUS VIA PUMP. THE PATIENT ALSO HAD TO VISIT THE EMERGENCY ROOM AND WAS TREATED WITH IV AND FLUIDS OF SALINE AND INSULIN. COMPANY DO NOT SEE BENT 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
    1522901 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6005455

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization