BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19482618 · Received June 7, 2024

    Report

    Report Number
    3003442380-2024-06956
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    April 23, 2024
    Report Date
    June 7, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016712
    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 1881938- DEVICE 3 OF 4

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT FOUR INFUSION SET CANNULA WAS BENT DUE TO WHICH HYPERGLYCEMIA AND TRACES OF KETONES OCCURS WITHIN 3 HOURS OF INSERTION. INFUSION SET WAS PLACED IN ABDOMEN. BLOOD GLUCOSE LEVEL WAS DISPLAYED HIGH AND TREATMENT IS DONE BY CORRECTION INJECTION VIA MDI. 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151303 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 6003410 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female