BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1880461 · Received October 8, 2010

    Report

    Report Number
    3004193489-2010-00223
    Event Type
    Other
    Date Received
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    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 WHILE ON VACATION, DROVE HIMSELF TO THE HOSPITAL BASED ON A HIGHER THAN EXPECTED RESULT OF "HI" (GREATER THAN 600 MG/DL) ON HIS BLOOD GLUCOSE METER. ACCORDING TO THE CONSUMER, WHEN THE EMERGENCY ROOM NURSE TESTED HIS BLOOD GLUCOSE ON THEIR UNKNOWN METER, GETTING AN UNKNOWN LOW RESULT. THE CONSUMER WAS TREATED WITH EMERGENT FOOD INTAKE TO RAISE HIS BLOOD SUGAR LEVEL. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER HAS NEVER PERFORMED A CONTROL SOLUTION TEST ON TEST STRIPS TO CHECK THEIR INTEGRITY BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THE METER WILL BE RETURNED FOR EVALUATION, HOWEVER, THE TEST STRIPS WERE USED AND DID NOT HAVE ANY LEFT TO SEND BACK 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention