BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 1900531 · Received October 29, 2010

    Report

    Report Number
    3004193489-2010-00244
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 29, 2010
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. SHOULD AN 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 254 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED TWO ADDITIONAL TESTS USING THE SAME METER AND STRIPS GETTING THE FOLLOWING RESULTS OF 64 MG/DL AND 63 MG/DL. DURING THE CALL WITH CUSTOMER SUPPORT, A CONTROL SOLUTION TEST WAS PERFORMED SHOWING THE TEST STRIPS TO FALL IN RANGE. THE DIFFERENCE IN THE CONSUMER'S 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 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA 1020210202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK