BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1842194 · Received August 20, 2010

    Report

    Report Number
    3004193489-2010-00172
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 8, 2010
    Report Date
    August 20, 2010
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 THAT A CONSUMER MADE A VISIT TO THE EMERGENCY ROOM BECAUSE SHE FELT LIGHT HEADED. THE EMERGENCY ROOM NURSE PERFORMED A BLOOD GLUCOSE TEST ON THE CONSUMER GETTING A RESULT OF 105 ON THE EMERGENCY ROOM BLOOD GLUCOSE METER. THEN THEY PERFORMED A TEST ON THE CONSUMER'S NOVA MAX GLUCOSE METER GETTING A RESULT OF 264 MG/DL AFTER RECEIVING HIGHER THAN EXPECTED RESULTS ON HER BLOOD GLUCOSE METER. DURING THE CALL TO CUSTOMER SUPPORT, A CONTROL SOLUTION TEST WAS PERFORMED SHOWING THE TEST STRIPS TO FALL IN RANGE. THE DIFFERENCE IN THE CONSUMER'S READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020209106

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK