BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 2112479 · Received April 28, 2011

    Report

    Report Number
    3004193489-2011-00041
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 28, 2011
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 "HI" (GREATER THAN 600 MG/DL) ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED TWO ADDITIONAL TESTS USING THE SAME METER AND STRIPS GETTING ANOTHER "HI" RESULTS. THE CONSUMER PERFORMED THREE MORE TESTS GETTING THE FOLLOWING RESULTS OF 81 MG/DL, 134 MG/DL AND 125 MG/DL. IT WAS DURING THE CALL TO CUSTOMER SUPPORT WHERE IT WAS DETERMINED THE CONSUMER DID NOT PERFORM THE TESTING PROCEDURE AS INSTRUCTED IN OUR DIRECTIONS FOR USE, WHICH MAY HAVE CONTRIBUTED TO THE ERRATIC RESULTS. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. DURING THE CALL TO CUSTOMER SUPPORT, THE CONSUMER STATED HAVING CONTROL TESTED HER 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 AND 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 1020210256

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK