BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT¿ XC

    MDR report key: 9237071 · Received October 25, 2019

    Report

    Report Number
    3003442380-2019-01851
    Event Type
    Injury
    Date Received
    October 25, 2019
    Product Code
    FPA
    UDI-DI
    05705244016712
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL IN THE RANGE OF 153-676 MG/DL. THEREFORE, ON (B)(6) 2019, THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL OF 676 MG/DL. THE PATIENT HAD KETONE LEVELS WHICH WAS NOT DANGEROUS/LIFE-THREATENING AS ASSESSED BY THE HEALTH ARE PROFESSIONAL. AFTER SPENDING THREE HOURS IN THE EMERGENCY ROOM, THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL AND SUBSEQUENTLY, HOSPITALIZED WITH HIGH BLOOD GLUCOSE LEVEL (474 MG/DL) AND THE PATIENT FELT TIRED. WHILE IN THE HOSPITAL, THE SITE WAS REMOVED, AND IT WAS FOUND THAT INFUSION SET'S CANNULA WAS BENT. THE PATIENT RECEIVED INSULIN AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THEREFORE, ON (B)(6) 2019, THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH NO PERMANENT DAMAGE. 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
    1036430 AUTOSOFT¿ XC INSET I 60/6 BLUE T-CAP FPA 5271716 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1