BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE 4 BASIC

    MDR report key: 268061 · Received March 3, 2000

    Report

    Report Number
    1810909-2000-00005
    Event Type
    Malfunction
    Date Received
    March 3, 2000
    Date of Event
    February 3, 2000
    Report Date
    March 2, 2000
    Manufacturer
    KDK CORPORATION
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS A USER OF THE GLUCOMETER ELITE 4 BLOOD GLUCOSE SYSTEM. CUSTOMER INDICATED THAT CUSTOMER PURCHASED EXCEL BRAND STRIPS AND IS RECEIVING HIGH THAN NORMAL RESULTS. BAYER DOES NOT RECOMMEND USE OF ANY OFF BRAND REAGENT WITH CO'S SYSTEM. CUSTOMER TESTED BLOOD SUGAR USING THE ELITE (BAYER) REAGENT STRIPS AND COMPARED THE RESULTS WITH TWO COMPARATIVE METHODS. ALL THREE RESULTS WERE GOOD. HOWEVER, WHEN THEY USED THE EXCEL OFF BRAND REAGENT CUSTOMER'S RESULTS WERE HIGHER. WHILE ON THE PHONE AN OFFER WAS MADE TO REVIEW THE OPERATION OF THE INSTRUMENT SYSTEM. THE CUSTOMER POLITELY REFUSED AND FELT THAT THE PROBLEM WAS NOT WITH GLUCOMETER ELITE BLOOD GLUCOSE METER BUT WITH THE EXCEL OFF BRAND REAGENT STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE 4 BASIC BLOOD GLUCOSE METER NBW KDK CORPORATION 3901N *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN