BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 1884172 · Received October 13, 2010

    Report

    Report Number
    3004193489-2010-00230
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    September 25, 2010
    Report Date
    October 15, 2010
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVALUATION. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING EMERGENT FOOD INTAKE TO RAISE HER BLOOD SUGAR LEVEL. BLOOD TESTS PERFORMED WITH NOVA METER AND TEST STRIPS REVEALED THAT THE DEVICE GAVE LOW VALUES SHOWING OUR DEVICE PERFORMED AS INTENDED. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS. THE METER AND TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVALUATION BECAUSE THIS IS A MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020209043

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK