BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19737127 · Received July 13, 2024

    Report

    Report Number
    3003442380-2024-14494
    Event Type
    Injury
    Date Received
    July 13, 2024
    Date of Event
    May 25, 2024
    Report Date
    July 13, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1911301 - MDR 3003442380-2024-14494- DEVICE 5 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4), EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED SIX INFUSION SET CANNULA WAS BENT ON (B)(6) 2024 TO (B)(6) 2024. THE BLOOD GLUCOSE LEVEL WAS DISPLAYED HIGH AND WAS MANAGED BY HOSPITALIZATION. THE ISSUE OCCURED WITHIN THREE OR MORE HOURS AFTER INSERTION. 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
    834605 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6004228 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Hospitalization| R