BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVESENSE PRESTO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 1584300 · Received January 15, 2010

    Report

    Report Number
    MW5014431
    Event Type
    Injury
    Date Received
    January 15, 2010
    Date of Event
    December 15, 2009
    Report Date
    January 15, 2010
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WENT TO THE EMERGENCY ROOM BECAUSE HE REC'D A RESULT IN THE HIGH 300'S -MG/DL- AFTER TESTING WITH HIS PRESTO METER. PT COULD NOT FIND PAPERWORK FROM ER AND HE COULD NOT ANSWER QUESTIONS REGARDING HIS READINGS, SUCH AS: WAS THE 300 MG/DL READING TAKEN AFTER EATING? HOW MUCH TIME HAD ELAPSED FROM HIS READING OF 300 MG/DL AND GOING TO THE EMERGENCY ROOM?.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVESENSE PRESTO BLOOD GLUCOSE MONITORING SYSTEM PRESTO NBW AGAMATRIX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability