BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 1070685 · Received July 3, 2008

    Report

    Report Number
    3004193489-2008-00486
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 3, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 218 MG/DL ON THEIR BLOOD GLUCOSE METER AT 12:16AM. THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT WHICH REQUIRED MEDICAL INTERVENTION. THE EMTS TOOK THE CONSUMER'S BLOOD GLUCOSE AT 12:44 AM GETTING A RESULT OF 29 MG/DL USING THEIR UNK GLUCOSE METER. THE CONSUMER DECLINED TO GO TO THE HOSPITAL AND WAS TREATED WITH FOOD TO BRING HIS SUGAR LEVELS UP. THE DIFFERENCE IN THE READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE METER IN QUESTION WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020207292

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK