BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1880459 · Received October 8, 2010

    Report

    Report Number
    3004193489-2010-00226
    Event Type
    Other
    Date Received
    October 8, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 8, 2010
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVALUATION. 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 CONTINUED TO ADMINISTER EXTRA UNPRESCRIBED ORAL MEDICATION BASED ON MULTIPLE HIGH READINGS ON THEIR BLOOD GLUCOSE METER. ACCORDING TO THE CONSUMER HE DID NOT EAT ANYTHING THROUGHOUT THE DAY. THE CONSUMER SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT, WHICH DID REQUIRE EMERGENT FOOD INTAKE TO HELP RAISE THE CONSUMER BLOOD GLUCOSE LEVEL. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020210174

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK