BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 1821639 · Received August 26, 2010

    Report

    Report Number
    3004193489-2010-00188
    Event Type
    Other
    Date Received
    August 26, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 26, 2010
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF 366 MG/DL ON THEIR BLOOD GLUCOSE METER. TWENTY MINUTES LATER, THE CONSUMER ADMINISTERED 10 UNITS OF INSULIN AND APPROXIMATELY, 45 MINUTES LATER WHILE WAITING TO EAT, THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. THE EMTS PERFORMED A BLOOD GLUCOSE TEST ON THE CONSUMER GETTING A RESULT OF 51 MG/DL ON THEIR UNK METER. THE EMTS TREATED THE CONSUMER WITH 2-3 GLUCOSE TABLETS TO HELP RAISE HIS BLOOD SUGAR LEVELS. THE CONSUMER REPORTED NOT ADMINISTERING ANY OTHER INSULIN THROUGHOUT THAT DAY BECAUSE, HE THOUGHT THE HUMIDITY WOULD AFFECT HIM. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS. THE METER AND TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVAL 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 CORP NA 1020209243

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK