BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE XL

    MDR report key: 279879 · Received May 19, 2000

    Report

    Report Number
    1810909-2000-00018
    Event Type
    Malfunction
    Date Received
    May 19, 2000
    Date of Event
    April 21, 2000
    Report Date
    May 19, 2000
    Manufacturer
    KDK CORPORATION
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CALLED AND INDICATED THAT THE ELITE XL METER IS PROVIDING ERRATIC TEST RESULTS WHEN COMPARED TO A LABORATORY METHOD. NO SPECIFIC VALUES WERE PROVIDED BY THE CUSTOMER HOWEVER CUSTOMER IS VERY CONCERNED AND WOULD LIKE TO KNOW WHAT IS WRONG WITH THE SYSTEM. WHILE ON THE PHONE ELECTRONIC CHECKS WERE PERFORMED AND WERE FOUND TO BE WITHIN SPECS. THE CUSTOMER THEN INFORMED CO THAT CUSTOMER WAS USING EXCEL OFF BRAND REAGENT STRIPS. CUSTOMER SERVICE TOLD THE CUSTOEMR THAT THESE REAGENT STRIPS ARE NOT MFG BY BAYER AND THEY SHOULD CONTACT THE MFR FOR FURTHER TROUBLESHOOTING. THE COMPLAINT IS CONSIDERED CLOSED FOR PURPOSES OF MDR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN