BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC MINIMED PARADIGM

    MDR report key: 747199 · Received October 13, 2005

    Report

    Report Number
    MW1036930
    Event Type
    Other
    Date Received
    October 13, 2005
    Date of Event
    October 6, 2005
    Report Date
    October 10, 2005
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZA
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR ATTENDED AN INSULIN PUMP INTRODUCTION SEMINAR AT HOSPITAL AND A SALESWOMAN FROM MEDTRONIC MINIMED GOT UP ON STAGE AND DEMONSTRATED AN INSULIN PUMP THAT ALSO SHOWS CONSTANT BLOOD SUGAR RESULTS. SHE SAID IT WILL BE AVAILABLE IN THE SPRING. SHE HAS DIABETES AND HAD IT INSERTED IN HER BODY. RPTR CHECKED WEBSITE AND COULD NOT FIND FDA APPROVAL FOR THE DEVICE. RPTR ASKS IF THIS TYPE OF ADVERTISING IS LEGAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM INSULIN PUMP & GLUCOSE READER LZA MEDTRONIC MINIMED NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other