BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19485266 · Received June 7, 2024

    Report

    Report Number
    3003442380-2024-06957
    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- MDR 3003442380-2024-06957- DEVICE 4 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
    1581157 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