BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1060898 · Received June 13, 2008

    Report

    Report Number
    3004193489-2008-00465
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 13, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 229 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER ADMINISTERED 26 UNITS OF INSULIN AT 9:00AM. THE CONSUMER DRANK TWO CUPS OF COFFEE, SWEET 'N-LOW WITH SOY MILK NO FOOD INTAKE AT THIS TIME. THE CONSUMER WENT FOR A WALK AND WHEN SHE RETURNED ACCORDING TO THE CONSUMER SHE TESTED HERSELF AGAIN GETTING RESULTS OF 238 MG/DL AND 220 MG/DL. ACCORDING TO THE CONSUMER, SHE DID NOT BELIEVE THE RESULTS TO BE CORRECT BECAUSE SHE FELT WEAK, DIZZY AND BEGAN TO SWEAT. THE CONSUMER REPORTED AT 12:50PM, SHE EXPERIENCED A HYPOGLYCEMIC EVENT WHICH DID NOT REQUIRE ANY MEDICAL INTERVENTION. IT WAS DISCOVERED THAT THIS CONSUMER HAS NOT HAD ANYTHING TO EAT ALL DAY. THE METER AND TEST STRIPS IN QUESTION 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 CORPORATION DIABETES PRODUCTS NA 1020208029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK