BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 4546442 · Received February 13, 2015

    Report

    Report Number
    3004193489-2015-00013
    Event Type
    Other
    Date Received
    February 13, 2015
    Date of Event
    January 15, 2015
    Report Date
    January 16, 2015
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE CALL TO CUSTOMER SUPPORT, THE CONSUMER ADMITTED "...USING THE SAME SITE FOR ALL THREE TESTS...". DURING THE FIRST CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. A CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING IN THE FOLLOW UP CALL WITH CUSTOMER SUPPORT SHOWING THE TEST STRIPS TO FALL IN RANGE. THE DIFFERENCE IN THE CONSUMER'S READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. TEST STRIP LOT #1020214149 EXPIRATION DATE: 07/2016 CONTROL SOLUTION LOT # 1030214093 RANGE: 82-127 MG/DL. NOVA MAX TEST STRIP INSERT - QUALITY CONTROL CHECKING THE SYSTEM CONTROL SOLUTION TEST: THE NOVA MAX CONTROL SOLUTION IS USED AS A QUALITY CONTROL CHECK TO MAKE SURE THAT YOUR BLOOD GLUCOSE MONITOR AND THE NOVA MAX GLUCOSE TEST STRIPS ARE WORKING CORRECTLY. DO A CONTROL SOLUTION TEST: EACH TIM YOU OPEN A NEW VIAL OF TEST STRIPS. NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVALUATION. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CONSUMER STATED, "...THAT THIS MORNING HE DID 3 TESTS BACK TO BACK THAT HE BELIEVES ARE TOO FAR APART FROM ONE AND ANOTHER: 180, 213, AND 132 MG/DL...". THE CONSUMER REPORTED THAT HE PERFORMED THREE BACK TO BACK BLOOD GLUCOSE TESTS ON HIS BLOOD GLUCOSE METER USING THE SAME METER AND STRIPS FROM THE SAME VIAL GETTING THE FOLLOWING RESULTS OF 180 MG/DL, 213 MG/DL AND 132 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107934 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020214149

    Patients

    Seq Age Sex Outcome Treatment
    1