BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUCOMETER ELITE XL

    MDR report key: 279883 · Received May 19, 2000

    Report

    Report Number
    1810909-2000-00017
    Event Type
    Other
    Date Received
    May 19, 2000
    Date of Event
    April 22, 2000
    Report Date
    May 19, 2000
    Manufacturer
    KDK CORPORATION
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT STATES THAT COMPLAINANT SENT EXCEL OFF BRAND BLOOD GLUCOSE REAGENT FROM USER. WHILE USING THESE OFF BRAND STRIPS COMPLAINANT RECEVIED A READING OF "LO" (LESS THAN 20 MG/DL) FOLLOWED BY A READING OF 170 MG/DL. ELECTRONIC CHECKS OF THE ELITE XL SYSTEM WERE SATISFACTORY. BAYER DIAGNOSTICS DOES NOT SUPPORT THE USE OF OFF BRAND REAGENT SINE CO DOES NOT KNOW THE PERFORMANCE CHARACTERISTICS NOR WERE THE SYSTEMS DESIGNED TO ACCOMMODATE REAGENT SUPPLIED BY OTHER MANUFACTURERS.

    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 UNKNOWN