BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19429639 · Received May 30, 2024

    Report

    Report Number
    3003442380-2024-04814
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 30, 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 1875072- MDR 3003442380-2024-04814- DEVICE 2 OF 3. E1: PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 3 INFUSION SET CANNULA BENT ON (B)(6) 2024 AFTER 3 HOURS OF INSERTION. INSERTION SITE WAS ABDOMEN. THE GLUCOSE LEVEL WAS OVER 501 MG/DL. THEREFORE, PATIENT WAS TREATED WITH CORRECTION INJECTION VIA IV BOLUS. CUSTOMER 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
    1129001 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003411

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male