BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19432395 · Received May 30, 2024

    Report

    Report Number
    3003442380-2024-04476
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    April 26, 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 1874986 - MDR 3003442380-2024-04476 - DEVICE 1 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT THREE INFUSION SET WAS BENT DUE TO WHICH HYPERGLYCEMIA OCCURS AFTER 3 HOURS OF INSERTION. BLOOD GLUCOSE LEVEL WAS 395 MG/DL. EVENT OCCURRED ON (B)(6) 2024. INFUSION SET WAS PLACED IN ABDOMEN. HIGH BLOOD GLUCOSE LEVEL WAS TREATED BY THE CORRECTION INJECTION VIA MDI AND CHANGED INFUSION SET. 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332141 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female