BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1880460 · Received October 8, 2010

    Report

    Report Number
    3004193489-2010-00222
    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
    TX, 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 SEVERAL WEEKS AGO, THE CONSUMER CALLED EMERGENCY SERVICES BASED ON A HIGHER THAN EXPECTED RESULT OF 340 MG/DL ON THEIR BLOOD GLUCOSE METER. WHEN THE EMTS ARRIVED THEY TESTED THE CONSUMER GETTING A RESULT OF 32 MG/DL ON THEIR UNKNOWN BLOOD GLUCOSE METER. THE CONSUMER WAS TREATED WITH EMERGENT FOOD INTAKE TO RAISE HIS BLOOD GLUCOSE 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 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 1020210181

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention