BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE XL

    MDR report key: 280871 · Received May 25, 2000

    Report

    Report Number
    1810909-2000-00021
    Event Type
    Malfunction
    Date Received
    May 25, 2000
    Date of Event
    April 25, 2000
    Report Date
    May 24, 2000
    Manufacturer
    KDK CORPORATION
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS THE PARENT OF AN INSULIN DEPENDENT DIABETIC. PARENT STATES THAT PT HAS BEEN A DIABETIC FOR A YEAR. DURING A RECENT COMPARISON OF BLOOD GLUCOSE READINGS BETWEEN 2 GLUCOMETER ELITE SYSTEMS PARENT'S STATED OBSERVING A DIFFERENCE IN READINGS. FOR EXAMPLE THE COMPLAINT METER READ 419 MG/DL WHILE ANOTHER METER READ 157MG/DL. WHILE ON THE PHONE, BOTH SYSTEMS WERE EVALUATED AND FOUND TO BE PERFORMING WITHIN EXPECTED LIMITS. THE CUSTOMER THEN STATED THAT THE PT WAS TAKEN TO AN EMERGENCY ROOM BECAUSE PT WAS LETHARGIC. AT THE EMERGENCY ROOM, A BLOOD SUGAR OF 61MG/DL. WAS OBTAINED. TWENTY MINUTES LATER A BLOOD SUGAR OF 106MG/DL WAS OBSERVED. NO OTHER MEDICATION OR FOOD WAS GIVEN BETWEEN READINGS. A REQUEST WAS MADE TO RETURN THE SYSTEMS FOR EVAL.

    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 5 YR