BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC

    MDR report key: 3231281 · Received July 15, 2013

    Report

    Report Number
    MW5030883
    Event Type
    Other
    Date Received
    July 15, 2013
    Date of Event
    July 13, 2013
    Report Date
    July 15, 2013
    Manufacturer
    MEDTRONIC, INC
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED THAT HER DAUGHTER USES THE MEDTRONIC QUICK SET PARADIGM AND SOMETIMES THE TUBING GETS KINKED UP UNDER THE SKIN AND INSULIN WILL NOT BE DELIVERED. RECENTLY THE TUBING KINKED UP THREE TIMES AND HER DAUGHTER WAS ADMITTED IN HOSPITAL ON (B)(6) 2013 FOR D.K.A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326730 MEDTRONIC QUICK SET PARADIGM FPA MEDTRONIC, INC 5012269

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR