BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 2163674 · Received June 10, 2011

    Report

    Report Number
    3004193489-2011-00058
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    May 29, 2011
    Report Date
    June 10, 2011
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    WHILE ON THE PHONE WITH CUSTOMER SUPPORT, THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING EMERGENT FOOD INTERVENTION AND EMERGENCY MEDICAL INTERVENTION. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS. THE METER AND TEST STRIPS IN QUESTION WILL NOT 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 1020210308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention