BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVESENSE KEYNOTE METER

    MDR report key: 2190685 · Received July 30, 2011

    Report

    Report Number
    MW5021566
    Event Type
    Malfunction
    Date Received
    July 30, 2011
    Date of Event
    July 30, 2011
    Report Date
    July 30, 2011
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SIGNIFICANTLY VARIABLE BLOOD GLUCOSE RESULTS ON REPEATED FINGERSTICK TESTS PERFORMED WITHIN A 5-MINUTE PERIOD. ALL TESTS WERE PERFORMED USING THE SAME METER AND ALL WITH TEST STRIPS FROM THE SAME VERY FRESH IN-DATE VIAL OF TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVESENSE KEYNOTE METER BLOOD GLUCOSE METER FOR HOME USE CGA AGAMATRIX, INC. KEYNOTE NA
    2 KEYNOTE TEST STRIPS BLOOD GLUCOSE METER FOR HOME USE CGA AGAMATRIX, INC HO19WA28A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other