BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1943969 · Received December 3, 2010

    Report

    Report Number
    3004193489-2010-00269
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 25, 2010
    Report Date
    December 3, 2010
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 193 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY TESTED AGAIN USING THE SAME METER AND TEST STRIPS GETTING A RESULT OF 61 MG/DL. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID CONTROL SOLUTION TEST THEIR TEST STRIPS FOR INTEGRITY BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE AND THE TEST STRIPS WAS DETERMINED TO BE IN RANGE. THE DIFFERENCE IN THE CONSUMER'S READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. AN ADDITIONAL CONTROL SOLUTION TEST WAS PERFORMED WHILE ON THE PHONE WITH CUSTOMER SUPPORT SHOWING THE TEST STRIPS TO FALL IN RANGE. THE METER AND TEST STRIPS 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 1020210202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK