BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19459064 · Received June 4, 2024

    Report

    Report Number
    3003442380-2024-05965
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    January 1, 2024
    Report Date
    June 4, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026032
    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 1884105 - MDR 3003442380-2024-05965- DEVICE 3 OF 8.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES, IT WAS REPORTED THAT ON (B)(6) 2024 , THE PATIENT EXPERIENCED ISSUES WITH 8 INFUSION SETS, ALL OF THE SAME TYPE. THE CANNULA OF THE INFUSION SET WAS BENT. THE SYMPTOMS WERE NOTICED WITHIN 3 HOURS OF INSERTION IN THE ABDOMEN. THE PATIENT REGULARLY ROTATES THE SITE LOCATION, AND THE SITE AREA WAS NOT IMPACTED. THE PATIENT CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF THE ISSUE WAS 180MG/DL. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149051 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 UNKNOWN 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female