BEUDAMED
    FDA Adverse Event Other Summary report: N

    KEYNOTE BLOOD GLUCOSE METER

    MDR report key: 1123770 · Received August 18, 2008

    Report

    Report Number
    3004637226-2008-00003
    Event Type
    Other
    Date Received
    August 18, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 18, 2008
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INITIAL COMPLAINT WAS THAT CONTROL WERE OUT OF RANGE. REPLACED METER TEST STRIPS, AND CONTROL SOLUTION. NOW VARIATIONS BETWEEN FINGER STICKS. PRODUCT NOT RETURNED. TEST STRIP RETAINS IN-HOUSE AND RESULTS WERE ACCEPTABLE WITH LITTLE VARIATION. SUSPECT USER ERROR.

    Description of Event or Problem · 1

    GLUCOSE READING BETWEEN MIDDLE, INDEX AND RING FINGER HAD LARGE VARIATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KEYNOTE BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-01843

    Patients

    Seq Age Sex Outcome Treatment
    1