BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 2845030 · Received November 8, 2012

    Report

    Report Number
    3004193489-2012-00074
    Event Type
    Other
    Date Received
    November 8, 2012
    Date of Event
    October 20, 2012
    Report Date
    November 7, 2012
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER CALLED INTO THE CUSTOMER SUPPORT BECAUSE SHE FELT LIGHT HEADED AND CONFUSED. THE CONSUMER REPORTED THAT SHE HAS BEEN GETTING HIGH RESULTS AND HER PHYSICIAN HAD RECENTLY CHANGED HER MEDICATION BASED ON HER HIGH RESULTS. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. IT WAS ALSO REVEALED THAT THE CONSUMER WAS USING EXPIRED TEST STRIP, WHICH MAY CONTRIBUTE TO THE LOSS OF INTEGRITY OF THE TEST STRIPS. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS. THE METER AND TEST STRIPS WILL NOT BE RETURNED BACK FOR EVALUATION. CONSUMER DECLINED TO RESPOND TO NOVA'S FOLLOW-UP PHONE CALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020209160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK