BEUDAMED
    FDA Adverse Event Other Summary report: N

    WAVESENSE PRESTO BLOOD GLUCOSE MONITORY SYSTEM

    MDR report key: 1358755 · Received April 8, 2009

    Report

    Report Number
    3005621222-2009-00001
    Event Type
    Other
    Date Received
    April 8, 2009
    Date of Event
    March 19, 2009
    Report Date
    April 8, 2009
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K073573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SENT REPLACEMENT METER, TEST STRIPS AND CONTROL ON (B)(6) 2009. REQUEST DEVICE IN QUESTION RETURN IN SELF ADDRESSED ENVELOPE THAT WAS PROVIDED TO CUSTOMER. DID NOT RECEIVE METER.

    Description of Event or Problem · 1

    CUSTOMER CALLED AND REPORTED THAT LAST NIGHT ON (B)(6) 2009, HE TESTED HIS BLOOD GLUCOSE AND OUR METER GAVE HIM A READING OF 180. HE TOOK HIS INSULIN BASED ON OUR RESULTS. THAT NIGHT HE WAS ILL AND REQUIRED TREATMENT FROM PARAMEDICS AT HIS HOUSE. HE HAD AN INSULIN REACTION. PARAMEDICS TOOK A GLUCOSE READING AT THE SCENE AND REPORTED THAT HIS BLOOD GLUCOSE WAS 33. TODAY HE RAN A CONTROL FOR THE FIRST TIME AND CONTROL WAS OUT OF RANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention