BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE 4 BASIC

    MDR report key: 280874 · Received May 25, 2000

    Report

    Report Number
    1810909-2000-00020
    Event Type
    Malfunction
    Date Received
    May 25, 2000
    Date of Event
    January 19, 2000
    Report Date
    May 24, 2000
    Manufacturer
    KDK CORPORATION
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINT INDICATED THAT THE GLUCOMETER ELITE 4 BASIC IS READING MUCH LOWER WHEN COMPARED TO ANOTHER METHOD. COMPLAINANT RECEIVING A RESULT IN THE 30 MG/DL RANGE WHILE A COMPETITIVE METHOD RAN AT APPROX THE SAME TIME GAVE A RESULT OVER 300 MG/DL. (EXACT VALUE UNKNOWN). WHILE ON THE PHONE, IT WAS LEARNED THAT THE CUSTOMER WAS USING EXCEL OFF BRAND REAGENT STRIPS. IT WAS EXPLAINED TO THE CUSTOMER THAT THIS OFF BRAND REAGENT WAS NOT SUPPLIED BY BAYER AND IT IS UNKNOWN HOW THESE OFF BRAND REAGENT STRIPS WORK IN A SYSTEM THAT WAS DESIGNED TO BE USED WITH ELITE SENSORS ONLY. REPLACEMENT REAGENT WAS PROVIDED TO THE CUSTOMER AND CONTROL TESTING, AS WELL AS ELECTRONIC CHECKS WERE SATISFACTORY. THE CUSTOMER WAS ADVISED TO CONTACT THE MFR OF THE EXCEL OFF BRAND REAGENT FOR FURTHER INVESTIGATION. THE COMPLAINT IS CONSIDERED CLOSED.

    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