BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1415037 · Received July 10, 2009

    Report

    Report Number
    MW5011956
    Event Type
    Injury
    Date Received
    July 10, 2009
    Date of Event
    May 14, 2009
    Report Date
    July 10, 2009
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PROBLEM IS WITH THE MEDTRONIC INFUSION SETS SUPPLIED TO ME BY MEDTRONIC LOT 8. FOR THE PAST 6 MONTHS OR LONGER I HAVE HAD UNEXPLAINED SEVERE HIGH AND LOW BLOOD SUGAR READINGS. MANY TIMES I WOULD CHECK MY B/S BEFORE PREACHING AND THEN EXPERIENCE EITHER A EXTREME HIGH OR LOW WHILE SPEAKING. ON THE APPROXIMATE DATE MENTIONED, I HAD CHECKED MY B/S BEFORE GOING TO LUNCH AND THEN WOKE UP IN ANOTHER TOWN WITH POLICE CARS AROUND ME AND THEY TOLD ME I ALMOST DROVE OFF A BRIDGE BEFORE STOPPING. SIMILAR EPISODES HAVE HAPPENED TO ME AT LEAST FOR THE PAST 6 MONTHS IF NOT LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INFUSION SETS, SETS NO. 8 FPA MEDTRONIC, INC. MEDTGRO;NIC 8

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening