BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE 4 BASIC

    MDR report key: 282159 · Received June 6, 2000

    Report

    Report Number
    1810909-2000-00025
    Event Type
    Malfunction
    Date Received
    June 6, 2000
    Date of Event
    May 8, 2000
    Report Date
    June 6, 2000
    Manufacturer
    KDK CORPORATION
    Product Code
    NBW
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINT INDICATES RECEIVING ERRATIC RESULTS FROM THE ELITE SYSTEM. FOR EXAMPLE RESULTS VARY FROM 200 TO 70 MG/DL WHEN PERFORMED AT THE SAME TIME. WHILE ON THE PHONE AN ATTEMPT WAS MADE TO REVIEW THE OPERATION OF THE SYSTEM. THE CUSTOMER DID NOT HAVE A CHECK STRIP TO EVALUATE THE ELECTRONICS. HOWEVER, IT WAS LEARNED THAT THE CUSTOMER WAS USING EXCELL OFF BRAND REAGENT STRIPS. REPLACE MATERIALS ARE BEING PROVIDED TO THE CUSTOMER FOR FURTHER TROUBLE SHOOTING. THE CUSTOMER WAS ADVISED TO CONTACT THE MANUFACTURER OF THE EXCELL OFF BRAND REAGENT STRIPS.

    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