BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE XL

    MDR report key: 282165 · Received June 6, 2000

    Report

    Report Number
    1810909-2000-00023
    Event Type
    Malfunction
    Date Received
    June 6, 2000
    Date of Event
    May 4, 2000
    Report Date
    June 2, 2000
    Manufacturer
    KDK CORPORATION
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS THE PARENT OF A 16 YEAR OLD INSULIN DEPENDENT DIABETIC. PARENT INDICATED THAT CHILD'S BLOOD SUGARS WHEN TESTED WITH THE ELITE SYSTEM HAVE BEEN IN THE 89-115MG/DL RANGE FOR THE PAST SEVERAL MONTHS. HOWEVER, DURING A RECENT VISIT AT CHILD'S PHYSICIAN CHILD'S HBA1C RESULTS WERE 11.7, WHICH TYPICALLY CORRELATES WITH BLOOD GLUCOSE IN THE 230MG/DL RANGE. PARENT WAS CONCERNED ABOUT THE PAST READINGS AND PURCHASED A COMPETITIVE SYSTEM AND BEGAN RECEIVING RESULTS IN THE LOW 200 MG/DL RANGE WHILE THE ELITE SYSTEM CONSISTENTLY GAVE RESULTS IN THE LOW 100'S MG/DL. THE CUSTOMER WAS NOT VERY COOPERATIVE IN PROVIDING INFORMATION RELATIVE TO THE SERIAL NUMBER OF THE INSTRUMENT AND PARENT REFUSED TO TROUBLE SHOOT THE SYSTEM. THE CUSTOMER DID PROVIDE INFORMATION RELATIVE TO THE LOT NUMBER OF REAGENT THAT IS BELIEVED AS BEING USED DURING THE "EVENT" PERIOD. RESERVE SAMPLES OF THIS LOT WILL BE TESTED. FOR PURPOSES OF MDR THIS COMPLAINT IS CONSIDERED CLOSED.

    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 16 YR