BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19518708 · Received June 12, 2024

    Report

    Report Number
    3003442380-2024-07767
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    February 6, 2024
    Report Date
    June 12, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016958
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR 1885139 - DEVICE 3 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SET CANNULA WAS BENT EVENT ON (B)(6) 2024. THE BLOOD GLUCOSE LEVEL WAS DISPLAYED HIGH AT THE TIME OF EVENT AND WAS MANAGED BY MULTIPLE DAILY INJECTIONS (MDI). THE EVENT OCCURED 3 OR MORE HOURS AFTER INSERTION. THE SITE OF INSERTION WAS AT ABDOMEN. THE INFUSION SET WAS IN USE UP TO A DAY. 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
    394480 AUTOSOFT XC UNO INSET I 110/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001729 UNKNOWN 05705244016958

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male