BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER BLOOD ELITE XL

    MDR report key: 275725 · Received April 17, 2000

    Report

    Report Number
    1810909-2000-00013
    Event Type
    Malfunction
    Date Received
    April 17, 2000
    Date of Event
    March 17, 2000
    Report Date
    April 17, 2000
    Manufacturer
    KDK CORPORATION
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS THE PARENT OF AN INSULIN DEPENDENT DIABETIC. COMPLAINANT STATES THAT THE GLUCOMETER ELITE IS "DEAD" BECAUSE THE NEW STRIPS THAT COMPLAINANT HAD BEEN GIVEN HAD SCRATCHED THE INTERNAL CONTACTS AS THEY WERE BEING INSERTED INTO THE STRIP SLOT. INVESTIGATION INTO THIS ISSUE WAS MADE. IT WAS LEARNED THAT THE CUSTOMER WAS USING EXCEL OFF BRAND REAGENT STRIPS. SINCE BAYER IS NOT MFG THESE ITEMS IT IS VERY POSSIBLE THAT THE TOLERANCE OF THE REAGENT CONTACTS WAS EXCEEDED AND CAUSED THE METER TO MALFUNCTION. BECAUSE THE METER MAY HAVE BEEN DAMAGED WITH THE USE OF THE EXCEL OFF BRAND REAGENT STRIPS A REPLACEMENT SYSTEM IS BEING PROVIDED. A REQUEST WAS MADE TO RETURN THE SYSTEM FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN