BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 881444 · Received July 16, 2007

    Report

    Report Number
    3004637226-2007-00001
    Event Type
    Other
    Date Received
    July 16, 2007
    Date of Event
    May 11, 2006
    Report Date
    July 13, 2007
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METER WAS REPLACED BY DISTRIBUTOR.

    Description of Event or Problem · 1

    CUSTOMER STATED, BGM IS INACCURATE. A CONTROL SOLUTION TEST TO CALIBRATE THE METER WAS NOT PERFORMED, SINCE THE DISTRIBUTOR DID NOT PROVIDE CUSTOMER WITH CONTROL SOLUTION. THE METER REQUIRES CONTROL SOLUTION TO CALIBRATE ACCURATE RESULTS. THE RETURNED METER WAS CALIBRATED IN-HOUSE AND PERFORMED AS EXPECTED WITHIN NORMAL RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY BLOOD GLUCOSE MONITORING SYSTEM BGMS NBW AGAMATRIX, INC. 8000-0067

    Patients

    Seq Age Sex Outcome Treatment
    1 YR