BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19493202 · Received June 8, 2024

    Report

    Report Number
    3003442380-2024-07119
    Event Type
    Malfunction
    Date Received
    June 8, 2024
    Date of Event
    April 24, 2023
    Report Date
    June 7, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018334
    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 1882090 - MDR - DEVICE 2 OF 7.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE (B)(6). IT WAS REPORTED THAT THE PATIENT FACED SIMILAR EVENTS OF BENT CANNULA WITH SEVEN INFUSION SETS. THE SYMPTOMS WERE NOTICED WITHIN 3 HOURS OF INSERTION. THE SITE OF INSERTION WAS ABDOMEN AND WAS ROTATED REGULARLY. PATIENT'S BLOOD GLUCOSE AT THE TIME OF EVENT WAS 350MG/DL. THEREFORE, PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES 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
    2325837 AUTOSOFT 90 UNO INSET II 60/9 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1002824 6002402 05705244018334

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male