BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 5015068 · Received August 19, 2015

    Report

    Report Number
    3004193489-2015-00116
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 28, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER'S COMPLAINT COULD NOT BE CONFIRMED. ANALYSIS OF THE RETURNED NOVA MAX PLUS BLOOD GLUCOSE MONITOR AND BLOOD GLUCOSE TEST STRIPS PERFORMED AS INTENDED. THE CUSTOMER'S ALLEGED DEFICIENCY COULD NOT BE REPLICATED. ALL PERFORMANCE RESULTS OBTAINED REVEALED THE DEVICE AND TEST STRIPS MET ALL TEST SPECIFICATIONS

    Description of Event or Problem · 1

    CONSUMER CALLED IN CONCERN ABOUT HIGH BLOOD GLUCOSE READING. IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF 222MG/DL ON THEIR BLOOD GLUCOSE METER. ACCORDING TO THE CONSUMER THEY TOOK ADDITIONAL MEDICATION BASED ON THE REPORTED RESULT WHICH DID NOT REQUIRE ANY MEDICAL INTERVENTION. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT PERFORM A CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE OF THEIR INITIAL TEST STRIPS FROM THE VIAL AS INSTRUCTED IN OUR DIRECTIONS FOR USE. A CONTROL SOLUTION TEST COULD NOT BE PERFORMED BECAUSE THE CONSUMER DID NOT HAVE ANY CONTROL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548567 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. 1020313213

    Patients

    Seq Age Sex Outcome Treatment
    1