BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEX GLUCOMETER

    MDR report key: 266318 · Received February 29, 2000

    Report

    Report Number
    MW1018270
    Event Type
    Malfunction
    Date Received
    February 29, 2000
    Date of Event
    February 1, 2000
    Report Date
    February 29, 2000
    Manufacturer
    BAYER CORP
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROBLEM HAPPENS REPEATEDLY. DEVICE IS USED TO TEST BLOOD GLUCOSE 6 TIMES A DAY. REPORTER STATES THAT DEVICE DISPLAYS AN ERRONEOUS ERROR CODE, E7, WHEN TEST STRIPS ARE INSERTED. THE TEST STRIPS COST MONEY AND BECAUSE OF THE ERROR CODES THE REPORTER IS USING 8 STRIPS PER DAY WHICH IS A 25% COST INCREASE. THE INCREASE IN USE OF STRIPS MEANS CO IS ABLE TO SELL MORE STRIPS. REPORTER HAS SPOKEN WITH CO WHICH ASSURED RPTR THAT REPORTER'S TESTING TECHNIQUE IS SATISFACTORY. IN ADDITION, ACCORDING TO THE REPORTER CO HAS ALSO RECEIVED NUMEROUS SIMILAR COMPLAINTS. REPORTER FEELS THAT IF THE FDA WERE AWARE OF THE NUMEROUS COMPLAINTS THAT THIS DEVICE WOULD NOT HAVE BEEN GIVEN ITS APPROVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEX GLUCOMETER BLOOD GLUCOSE MONITOR CFR BAYER CORP UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR