BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 582568 · Received March 17, 2005

    Report

    Report Number
    2954323-2005-00079
    Event Type
    Injury
    Date Received
    March 17, 2005
    Date of Event
    February 23, 2005
    Report Date
    March 17, 2005
    Manufacturer
    THERASENSE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER TOOK A BLOOD GLUCOSE READING AND BEGAN TO EXERCISE. THEY BEGAN TO FEEL "FUNNY" AND LOW. THEY TOOK AN UNKNOWN MEDICATION AND BEGAN TO FEEL HOT AND COLD FLASHES. THEY DRANK SOME SODA AND HAD SOME SUGAR. CUSTOMER BEGAN TO TAKE READINGS APPROXIMATELY ONE MINUTE APART WITH RESULTS OF 128, 95, 117, 78, 109, 179, 173, 236, 76, 80, 50, 250, 263, 119, 240, 145, 401, 97, 159, 111, 295, 222, 388, HI, AND 404 MG/DL. CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM WHERE IT WAS DISCOVERED THAT THEIR BLOOD GLUCOSE LEVEL WAS LOW. THEY WERE TREATED INTRAVENOUSLY AND PROVIDED ORANGE JUICE AND FOOD. CUSTOMER'S METER CALIBRATION CODE WAS SET INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR THERASENSE, INC. * 0429539

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention