BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE 4 BASIC

    MDR report key: 280869 · Received May 25, 2000

    Report

    Report Number
    1810909-2000-00022
    Event Type
    Malfunction
    Date Received
    May 25, 2000
    Date of Event
    April 24, 2000
    Report Date
    May 24, 2000
    Manufacturer
    KDK CORPORATION
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT CALLED AND INDICATED RUNNING A BLOOD GLUCOSE TEST TWO HOURS AFTER EATING. THE FIRST RESULT WAS 52MG/DL AND THEN COMPLAINANT RAN ANOTHER TEST AND RECEIVED A RESULT OF 170MG/DL. WHILE ON THE PHONE, ELECTRONIC CHECKS WERE PERFORMED AND WERE FOUND SATISFACTORY. THE CUSTOMER INDICATED USING EXCEL OFF BRAND REAGENT STRIPS. SINCE THIS OFF BRAND REAGENT IS NOT SUPPLIED BY BAYER, THE PERFORMANCE CHARACTERISTICS ARE NOT KNOWN. THE CUSTOMER WAS ADVISED TO CONTACT THE MFR OF THE EXCEL OFF BRAND REAGENT STRIPS FOR FURTHER COMPLAINT EVAL. THE COMPLAINT IS CONSIDERED CLOSED FOR PURPOSES OF MDR.

    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