BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 1853457 · Received September 28, 2010

    Report

    Report Number
    3004637226-2010-00001
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    December 15, 2009
    Report Date
    January 15, 2010
    Manufacturer
    AGAMATRIX, INC
    Product Code
    NBW
    PMA / PMN Number
    K073573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REQUESTED METER BE RETURNED FOR EVAL. A REPLACEMENT METER WAS SENT WITHIN 24 HRS. THE PT COULD NOT PROVIDE ANY ADDITIONAL INFO TO MANUFACTURER.

    Description of Event or Problem · 1

    PT WENT TO THE EMERGENCY ROOM BECAUSE HE RECEIVED A READING IN THE HIGH 300'S (MG/DL) AFTER TESTING WITH HIS PRESTO METER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR