BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19494822 · Received June 8, 2024

    Report

    Report Number
    3003442380-2024-07308
    Event Type
    Malfunction
    Date Received
    June 8, 2024
    Date of Event
    February 1, 2024
    Report Date
    June 8, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1883668 - DEVICE 8 OF 10. E1: PATIENT COUNTRY: UNITED STATES

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED AN ISSUE WITH TEN INFUSIONS SET CANNULAS WERE KINKED. THE EVENTS EXACT DATES WERE UNKNOWN. THE PATIENT REPORTED ISSUE STARTING FROM FEBRUARY 2024 UNTIL APRIL 20TH BEING THE MOST RECENT ISSUE. THE EVENT WAS NOTICED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS ABDOMEN. THE PATIENT REPORTED HIGH BLOOD GLUCOSE LEVEL OF 300 MG/DL VALUE. THE PATIENT REPLACED 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
    2319013 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6003176 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female