BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19474823 · Received June 6, 2024

    Report

    Report Number
    3003442380-2024-06532
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1880752 - MDR 3003442380-2024-06532 - DEVICE 1 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED SIMILAR EVENTS OF BENT CANNULA WITH SIX INFUSION SETS. THE SYMPTOMS WERE NOTICED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS ABDOMEN AND WAS BEING ROTATED REGULARLY. TO ADDRESS TEH HIGH BG LEVEL THE PATIENT HYDRATED AND EXERCISED. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. 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
    7017 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003579 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female