BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVESENSE JAZZ GLUCOSE METER

    MDR report key: 1781742 · Received July 24, 2010

    Report

    Report Number
    MW5016878
    Event Type
    Malfunction
    Date Received
    July 24, 2010
    Date of Event
    July 24, 2010
    Report Date
    July 24, 2010
    Manufacturer
    AGAMATRIX, INC
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAVESENSE JAZZ GLUCOSE METER PROBLEMS. I AM A TYPE 1 DIABETIC AND NEED TO TEST 4 TIMES DAILY. THIS IS THE SECOND REPLACEMENT METER THAT I HAVE RECEIVED FROM AGAMATRIX. I RECEIVED THIS REPLACEMENT METER YESTERDAY AND HAVE RECEIVED 4 ERROR CODE #7 -METER PROBLEMS THAT ARE BEYOND YOUR CONTROL-CONTACT CUSTOMER SERVICE. CUSTOMER SERVICE IS NOT OPEN ON WEEKENDS, OF COURSE. THE DAY I GOT THE METER I DID THREE TESTS THAT GAVE ANTICIPATED RESULTS. TODAY, ALL TESTS GIVE THE CODE 7 ERROR. I BELIEVE THERE IS A QUALITY CONTROL ISSUE IN THE MFG PROCESS FOR THIS METER OR THE JAZZ TEST STRIPS. I HAVE USED VARIOUS GLUCOSE METERS FOR OVER 20 YRS AND NEVER HAVE HAD SUCH AN UNRELIABLE PRODUCT BEFORE. I AM UNABLE TO TEST MY BLOOD SUGAR WHICH IS A NECESSITY. THE METER PROMOTIONAL MATERIAL DESCRIBES A WELL THOUGHT OUT METER. UNFORTUNATELY, IT IS POORLY MADE AND THEREFORE UNRELIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVESENSE JAZZ GLUCOSE METER NONE NBW AGAMATRIX, INC JAZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other