BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFTÂ 90

    MDR report key: 19871494 · Received July 31, 2024

    Report

    Report Number
    3003442380-2024-18344
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    June 18, 2024
    Report Date
    July 31, 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 1926535 - MDR 3003442380-2024-18344 - DEVICE 2 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 2 INFUSION SET CANNULA KINKED EVENT ON 18-JUN-2024 AFTER 3 OR MORE HOURS OF INSERTION. INSERTION SITE WAS ABDOMEN. INFUSION SET HAS BEEN USED FOR 36 HOURS. CUSTOMER REGULARLY ROTATE SITE LOCATION. THE BLOOD GLUCOSE LEVEL WAS 200 MG/DL. CUSTOMER CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. CUSTOMER 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
    884973 AUTOSOFTÂ 90 INSET II 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1000282 6005000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female