BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19518712 · Received June 12, 2024

    Report

    Report Number
    3003442380-2024-07765
    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 1 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 06-FEB-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
    137109 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