BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19737270 · Received July 14, 2024

    Report

    Report Number
    3003442380-2024-14150
    Event Type
    Malfunction
    Date Received
    July 14, 2024
    Date of Event
    June 2, 2024
    Report Date
    July 14, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018181
    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 1912327 - MDR 3003442380-2024-14150 - DEVICE 1 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SETS CANNULA KINKED EVENTS ON 2-JUN-2024. THE EVENTS OCCURRED WITHIN 3 HOURS OF INSERTION AND THE INSERTION SITE WAS AT ABDOMEN. THE BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS 260MG/DL AND THE PATIENT RESOLVED THE EVENT BY REPLACING INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. UNOMEDICAL 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
    210916 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 UNKNOWN 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female