BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1040794 · Received May 9, 2008

    Report

    Report Number
    3004193489-2008-00396
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 9, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 440 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED ANOTHER THREE TESTS USING THE SAME METER AND STRIPS GETTING THE FOLLOWING RESULTS: 445 MG/DL, 349 MG/DL, 432 MG/DL. THEN OPENED A NEW VIAL OF NOVA TEST STRIPS USING THE SAME METER, GETTING A RESULT OF 104 MG/DL. THE DIFFERENCE IN THE READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE 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 CORP NA 1020207240

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK