BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUCOMETER ELITE 4 DATE

    MDR report key: 403884 · Received June 25, 2002

    Report

    Report Number
    1810909-2002-00139
    Event Type
    Other
    Date Received
    June 25, 2002
    Date of Event
    June 1, 2002
    Report Date
    June 23, 2002
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED FROM A CUSTOMER THAT REPORTED WHEN THEY USED EXCEL OFF BRAND REAGENT THE METER WOULD NOT COUNTDOWN AND PROVIDE A RESULT. NO BLOOD SUGAR RESULT TO A DIABETIC COULD REPRESENT A SERIOUS MEDICAL CONDITION. WHILE ON THE PHONE A REVIEW OF THE SYSTEM WAS CONDUCTED. ELECTRONIC CHECKS WERE SATISFACTORY. IT WAS EXPLAINED TO THE CUSTOMER THAT BAYER DOES NOT PROVIDE OR SUPPORT THE USE OF AN OFF BRAND REAGNET. BAYER SUPPLIED PRODUCT WAS PROVIDED AND THE CUSTOMER WAS ENCOUNRAGED TO CONTACT THE 24/7 CUSTOMER SERVICE LINE IF ANY ADDITIONAL PROBLEMS WERE ENCOUNTERED.

    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 Other