BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 2060912 · Received March 14, 2011

    Report

    Report Number
    3004193489-2011-00022
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 11, 2011
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF 570 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY TESTED AGAIN USING THE SAME METER AND TEST STRIPS GETTING A RESULT OF 254 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 TO FALL IN RANGE. THE DIFFERENCE IN THE CUSTOMER'S READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE TEST STRIPS WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020210305

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK