BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19429434 · Received May 30, 2024

    Report

    Report Number
    3003442380-2024-04429
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    March 1, 2024
    Report Date
    May 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1874916 - MDR 3003442380-2024-04429 - DEVICE 1 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SET CANNULA KINKED. THE EVENTS OCCURED BETWEEN 01-MAR-2024 AND 16-APR-2024.THE EVENTS OCCURED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS AT THE ABDOMEN AND THIGH IN ROTATION. THE BLOOD GLUCOSE LEVEL WAS HIGH WITH PRESENCE OF HIGH/LARGE KETONES AT THE TIME OF EVENTS. THEREFORE THE PATIENT WAS TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION (MDI). THE PATINET WAS IN HOSPITAL AND DOES NOT HAVE ACESS TO INFUSION SET PACKAGING.THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. UNOMEDICAL DO NOT SEE BENT/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
    1225192 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention