BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE XL

    MDR report key: 275718 · Received April 20, 2000

    Report

    Report Number
    1810909-2000-00014
    Event Type
    Malfunction
    Date Received
    April 20, 2000
    Date of Event
    March 17, 2000
    Report Date
    April 20, 2000
    Manufacturer
    KDK CORPORATION
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS A TYPE II DIABETIC. COMPLAINANT DID A BLOOD GLUCOSE MEASUREMENT USING THE GLUCOMETER ELITE XL AND OBTAINED A RESULT OF 155MG/DL. NOT FEELING WELL, COMPLAINANT WENT TO A LOCAL EMERGENCY ROOM WHERE THE BLOOD GLUCOSE WAS TESTED (METHOD UNKNOWN) AND A RESULT OF 682MG/DL WAS REPORTED. THE COMPLAINANT WAS HOSPITALIZED AND WAS TREATED WITH INTRAVENOUS INSULIN. WHILE ON THE PHONE A REVIEW OF THE OPERATION OF THE SYSTEM WAS CONDUCTED. CHECK PADDLE RESULTS WERE CONSISTENTLY HIGH OUT OF SPECIFICATION. THE CUSTOMER DID NOT HAVE ANY CONTROL SOLUTION FOR FURTHER INVESTIGATION. SINCE THE CHECK PADDLE WAS OUT OF SPECIFICATION THE METER SYSTEM WILL BE RETURNED FOR EVALUATION. REPLACEMENT MATERIALS ARE BEING PROVIDED TO THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN