BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19902596 · Received August 4, 2024

    Report

    Report Number
    3003442380-2024-18992
    Event Type
    Injury
    Date Received
    August 4, 2024
    Date of Event
    June 16, 2024
    Report Date
    July 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 1931650 - MDR 3003442380-2024-18992 - 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 TWO KINKED CANNULA EVENTS ON (B)(6)2024 AND(B)(6)2024. THE EVENT OCCURRED WITHIN THREE HOURS OF INSERTION. THE INFUSION SET WAS INSERTED IN ABDOMEN. BLOOD GLUCOSE LEVEL REPORTED DURING THE EVENT WAS 300 MG/DL. PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. 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
    1025568 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 37 YR Male Required Intervention