BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE XL

    MDR report key: 240525 · Received September 10, 1999

    Report

    Report Number
    1810909-1999-00009
    Event Type
    Malfunction
    Date Received
    September 10, 1999
    Date of Event
    August 11, 1999
    Report Date
    September 10, 1999
    Manufacturer
    KDK
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS AN INSULIN DEPENDENT DIABETIC. HE INDICATED THAT ON OR ABOUT 8/11 HE "FELT TERRIBLE AND COULD HARDLY WALK". HE TESTED HIS BLOOD SURGAR AT 2:00 PM WITH THE GLUCOMETER ELITE XL SYSTEM AND A RESULT OF 136MG/DL. SINCE HE WAS NOT FEELING WELL HE CALLED 911. UPON THEIR ARRIVAL THEY TESTED HIS BLOOD SUGAR AND RECEIVED A RESULT OF 40MG/DL. THE TIME DIFFERENCE BETWEEN READINGS AND THE METHOD USED IS UNK. THE COMPLAINANT WAS TRANSPORTED TO THE HOSP WHERE A BLOOD GLUCOSE READING OF 42 MG/DL WAS OBTAINED. HE WAS GIVEN SUGAR WATER AND FOOD AND WAS RELEASED LATER THAT EVENING. A REQUEST TO RETURN THE ENTIRE SYSTEM FOR EVALUATION WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE XL BLOOD GLUCOSE METER CGA KDK 3901A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN