BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19846721 · Received July 27, 2024

    Report

    Report Number
    3003442380-2024-17093
    Event Type
    Malfunction
    Date Received
    July 27, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 27, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1923618- MDR 3003442380-2024- 17093- DEVICE 1 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SETS CANNULA KINKED EVENTS ON (B)(6) 2024 AND (B)(6) 2024. THE PATIENT NOTICED SYMPTOMS OVER THREE HOURS OF INSERTION. INSERTION SITE WAS ABDOMEN FOR 1ST EVENT AND ARM FOR 2ND EVENT. PATIENT REGULARLY ROTATED SITE LOCATION. FURTHERMORE, PATIENT CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. THE BLOOD GLUCOSE LEVEL WAS NOTICED 401-500MG/DL AT THE TIME OF IST EVENT AND 470MG/DL AT THE TIME OF 2ND EVENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484652 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female