BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19663178 · Received July 3, 2024

    Report

    Report Number
    3003442380-2024-11458
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    February 20, 2024
    Report Date
    July 3, 2024
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 1925716 - MDR 3003442380-2024-11458 - DEVICE 10 OF 10.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE TEN INFUSION SET CANNULA WAS KINKED AND PATIENT FACES SYMPTOMS WITHIN 3 OR MORE HOURS AFTER INSERTION. THE SITE OF INSERTION IS ABDOMEN, UPPER BUTTOCKS & THIGH AND INFUSION SET IS LONG FOR 12 HOURS. THE BLOOD GLUCOSE LEVEL WAS 300 MG/DL. 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
    801157 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA 1001680 6002634 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female