BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 2864544 · Received December 6, 2012

    Report

    Report Number
    3004193489-2012-00078
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 5, 2012
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL WHEN A CONSUMER WAS PERFORMING A KETONE TEST HE RECEIVED A GLUCOSE STRIP PROMPT ON THE METER APPEARED AND NOT A KETONE PROMPT. DURING THE CALL TO CUSTOMER SUPPORT, A BLOOD GLUCOSE TEST WAS PERFORMED USING ANOTHER KETONE TEST STRIP AND AGAIN THE TESTER DISPLAYED "GLU" PROMPT RATHER THAN THE "KET" PROMPT. THE CONSUMER CONTINUED TO TEST AND RECEIVED A BLOOD GLUCOSE READING WITH THE KETONE TEST STRIP. THE METER WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA 1510211091

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK