BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 2492419 · Received March 12, 2012

    Report

    Report Number
    3004193489-2012-00013
    Event Type
    Other
    Date Received
    March 12, 2012
    Date of Event
    February 22, 2012
    Report Date
    March 9, 2012
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING EMERGENT FOOD INTAKE TO HELP RAISE HER BLOOD GLUCOSE LEVEL. THE CONSUMER HABITUALLY ADMINISTERS THE SAME AMOUNT OF 40 UNITS OF INSULIN EVERY DAY. TESTING WITH NOVA METER AND TEST STRIPS REVEALED THAT THE DEVICE GAVE LOW VALUES SHOWING OUR DEVICE PERFORMED AS INTENDED. 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 IN QUESTION 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 1020211227

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention