BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE 4 DATE

    MDR report key: 380950 · Received February 19, 2002

    Report

    Report Number
    1810909-2002-00011
    Event Type
    Malfunction
    Date Received
    February 19, 2002
    Date of Event
    January 30, 2002
    Report Date
    February 19, 2002
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED THAT WHEN CUSTOMER USED EXCEL OFF BRAND REAGENT STRIPS CUSTOMER'S BLOOD SUGAR RESULTS WERE SIGNIFICANTLY DIFFERENT. AS AN EXAMPLE, THE CUSTOMER STATED THAT CUSTOMER REC'D A READING OF 47 MG/DL AND THEN 200 MG/DL. THESE RESULTS WERE GENERATED FROM SEPARATE FINGER STICKS AND DONE AT APPROX THE SAME TIME. THE DIFFERENCE IN READINGS COULD BE CLINICALLY SIGNIFICANT. WHILE ON THE PHONE A REVIEW OF THE SYSTEM WAS CONDUCTED. ELECTRONIC CHECKS WERE PERFORMED AND WERE SATISFACTORY. IT WAS EXPLAINED TO THE CUSTOMER THAT BAYER DOES NOT PROVIDE OR SUPPORT THE USE OF AN OFF BRAND REAGENT. REPLACEMENT PRODUCT WAS PROVIDED TO THE CUSTOMER. THE COMPLAINT IS CONSIDERED CLOSED FOR PURPOSES OF MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE 4 DATE BLOOD GLUCOSE METER NBW ARKRAY, INC. 3901B *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN