BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 10256395 · Received July 10, 2020

    Report

    Report Number
    3003442380-2020-00322
    Event Type
    Malfunction
    Date Received
    July 10, 2020
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    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'S INFUSION SET'S TUBING THAT CONNECTS TO SITE BROKE OFF FROM THE SITE. THE SITE REMAINED ATTACHED TO BODY AND THIS OCCURRED ABOUT ONE MONTH AGO. AT THE TIME OF THE INCIDENT, HER BLOOD GLUCOSE LEVEL WAS ABOUT 220-290 MG/DL. THERE WAS NO DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. FURTHER, SHE REPLACED THE INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724006 AUTOSOFT 90 INSET II 60/9 PINK FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1