BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 2935013 · Received January 25, 2013

    Report

    Report Number
    3004193489-2013-00002
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 24, 2013
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVALUATION. 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 160 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED ANOTHER TEST USING THE SAME STRIPS GETTING AND ANOTHER NOVA METER GETTING A RESULT OF 40 MG/DL. DURING THE CALL TO CUSTOMER SUPPORT, THE CONSUMER STATED HAVING CONTROL TESTED THEIR TEST STRIPS WHEN THEY WERE OPENED AND THE TEST STRIPS CONTROL SOLUTION FELL INTO RANGE. ANOTHER CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING SHOWING THE TEST STRIPS TO FALL IN RANGE. THE DIFFERENCE IN THE CONSUMER'S READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE METER WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36237 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA 1020512087

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK