BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19847530 · Received July 27, 2024

    Report

    Report Number
    3003442380-2024-17234
    Event Type
    Malfunction
    Date Received
    July 27, 2024
    Date of Event
    January 21, 2024
    Report Date
    July 27, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1923514- MDR 3003442380-2024-17234- DEVICE 6 OF 12.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER 1923514. EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED TWELVE INFUSION SET KINKED EVENTS ON 21-JAN-2024. THE EVENTS OCCURRED AFTER THREE HOURS OF INSERTION. THE INSERTION SITE WAS AT THE ABDOMEN. THE BLOOD GLUCOSE LEVELS WAS 200 MG/DL AT THE TIME OF EVENTS. THE PATIENT REPLACED INFUSION SETS 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922294 AUTOSOFT 90 UNO INSET II 110/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002818 6000184

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male