BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 2121745 · Received May 20, 2011

    Report

    Report Number
    3004193489-2011-00047
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 20, 2011
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 "LO" (LESS THAN 20 MG/DL) ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY TESTED AGAIN USING THE SAME METER AND TEST STRIPS GETTING A RESULT OF 119 MG/DL. A CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING WITH CUSTOMER SUPPORT SHOWING THE TEST STRIPS TO FALL IN RANGE. THE DIFFERENCE IN THE CONSUMER'S READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020210308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK