BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20318697 · Received September 27, 2024

    Report

    Report Number
    3003442380-2024-27214
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 3, 2024
    Report Date
    August 29, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022386
    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 1991282 - MDR 3003442380-2024-27214 - DEVICE 1 OF 4.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 03-AUGUST-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED 4 INFUSION SETS CANNULA KINKED EVENTS ON (B)(6) 2024, (B)(6) 2024, (B)(6) 2024, AND (B)(6) 2024 WITHIN 3 HOURS AFTER INSERTION. THE SITE OF INSERTION WAS UPPER ARM AND THIGH. THE BLOOD GLUCOSE WAS REPORTED 400 MG/DL AND TREATED WITH BOLUS VIA PUMP AND MULTI-DAILY INJECTION (MDI). PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. 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
    1708929 AUTOSOFT XC UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1006922 6006449 05705244022386

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female