BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 8404941 · Received March 8, 2019

    Report

    Report Number
    3004193489-2019-00003
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Report Date
    February 26, 2019
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    UDI-DI
    00385480434355
    PMA / PMN Number
    K09154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANTS ALLEGED DEFICIENCY COULD NOT BE CONFIRMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DHR FOR THE METER WAS COMPLETE AND CONTAINED ALL RELEVANT DATA INDICATING THE PRODUCT PUT INTO FINISHED GOODS MET ALL SPECIFICATIONS. NOVA BIOMEDICAL WILL CONTINUE TO MONITOR AS PART OF OUR POST MARKET SURVEILLANCE PROGRAM.

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORT OF ANY ADVERSE EVENT ATTRIBUTED TO THE MISSING DIGIT ON THE DISPLAY OF THE METER. THE METER IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    COMPLAINANT STATED HIS METER SCREEN ONLY DISPLAYS 2 DIGITS OF HIS BLOOD GLUCOSE READING (1ST AND 2ND DIGITS ONLY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196168 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION 43435 1020218176 00385480434355

    Patients

    Seq Age Sex Outcome Treatment
    1