BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1884175 · Received October 15, 2010

    Report

    Report Number
    3004193489-2010-00234
    Event Type
    Other
    Date Received
    October 15, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 15, 2010
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL VIA A TRANSLATOR, THAT A CONSUMER CALLED INTO THE CUSTOMER SUPPORT DEPT ASKING WHAT TO DO WHEN THE BLOOD GLUCOSE METER DISPLAYS THE LETTERS, "LO". WHEN THE CUSTOMER SUPPORT REP EXPLAINED TO THE CONSUMER WHAT THE LETTERS, "LO" MEANT, THE CONSUMER TERMINATED THE CALL. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS. THE CONSUMER'S BLOOD GLUCOSE READINGS WERE LOW SHOWING THE DEVICE TO BE PERFORMING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention