BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 2469928 · Received February 20, 2012

    Report

    Report Number
    3004193489-2012-00007
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 17, 2012
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 80 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED THREE ADDITIONAL TESTS USING THE SAME METER AND STRIPS GETTING THE FOLLOWING RESULTS OF 100 MG/DL, 120 MG/DL AND 125 MG/DL. 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 FALL IN RANGE. THE DIFFERENCE IN THE CONSUMER'S READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE METER AND TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020410

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK