BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YPSOPUMP INSET

    MDR report key: 19901901 · Received August 3, 2024

    Report

    Report Number
    3003442380-2024-18742
    Event Type
    Malfunction
    Date Received
    August 3, 2024
    Date of Event
    July 4, 2024
    Report Date
    July 4, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET CANNULA KINKED EVENT. THE BLOOD GLUCOSE LEVEL WAS REPORTED 400 MMOL/L. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375379 YPSOPUMP INSET UNO INSET II 80/6 GREY Y-CAP 10PAK INT FPA UNOMEDICAL A/S 86-080-52B6 6004044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown