BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET, INSET II, T:90

    MDR report key: 19926621 · Received August 7, 2024

    Report

    Report Number
    3003442380-2024-19357
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 8, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026001
    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 1933060 - MDR 3003442380-2024-19357 - DEVICE 1 OF 9.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT COMPLAINED ABOUT NINE INFUSION SETS KINKED CANNULA WITHIN 3 HOURS OF INSERTION ON (B)(6) 2024 AT ABDOMEN, WHICH CAUSE THE PATIENT'S BLOOD GLUCOSE WAS ELEVATED TO 260 MG/DL. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. COMPANY 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221357 INSET, INSET II, T:90 INSET I 60/6 GREY T-CAP FPA UNOMEDICAL A/S 1010900 6004795 05705244026001

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female