BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 2445500 · Received February 6, 2012

    Report

    Report Number
    3004193489-2012-00005
    Event Type
    Other
    Date Received
    February 6, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 3, 2012
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF 44 MG/DL ON THEIR BLOOD GLUCOSE METER AND EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. WHEN THE EMTS ARRIVED THEY TESTED THE CONSUMER GETTING A LOW RESULT OF THEIR BLOOD GLUCOSE METER. THE CONSUMER WAS TREATED WITH EMERGENT FOOD INTAKE TO RAISE HER BLOOD GLUCOSE LEVEL. TESTING WITH THE NOVA METER AND TEST STRIPS REVEALED THAT THE DEVICE GAVE A LOW VALUE SHOWING OUR DEVICE PERFORMED AS INTENDED. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA 1020211193

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention