BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUCOMETER ELITE 4 BASIC

    MDR report key: 399724 · Received June 6, 2002

    Report

    Report Number
    1810909-2002-00104
    Event Type
    Other
    Date Received
    June 6, 2002
    Date of Event
    May 8, 2002
    Report Date
    June 5, 2002
    Manufacturer
    ARKRAY, INC
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED THAT REPORTED THAT A CUSTOMER WHEN USING EXCEL OFF BRAND REAGENT STRIPS IN CUSTOMER'S GLUCOMETER ELITE SYSTEM WAS RECEIVING ERRATIC RESULTS. EXAMPLES WERE 253, 198, 200, AND 134 MG/DL. THESE DIFFERENT READINGS COULD BE CLINICALLY SIGNIFICANT. WHILE ON THE PHONE A REVIEW OF THE OPERATION OF THE SYSTEM WAS ATTEMPTED. AT THE TIME OF THE CALL TESTING MATERIALS WERE NOT AVAILABLE. THESE WERE PROVIDED. THE CUSTOMER WAS RE-CONTACTED AND THE TESTING CONTINUED. THE SYSTEM PERFORMANCE WAS SATISFACTORY. IT WAS EXPLAINED TO THE CUSTOMER THAT BAYER DOES NOT PROVIDE OR SUPPORT THE USE OF AN OFF BRAND REAGENT. 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 ARKRAY, INC 3901N *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization