BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 3596362 · Received January 15, 2014

    Report

    Report Number
    3004193489-2014-00005
    Event Type
    Other
    Date Received
    January 15, 2014
    Date of Event
    January 4, 2014
    Report Date
    January 4, 2014
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020213212, EXPIRATION DATE: 7/2015. NOVA MAX TEST STRIP - QUALITY CONTROL CHECKING THE SYSTEM CONTROL SOLUTION TEST: THE NOVA MAX CONTROL SOLUTION IS USED AS A QUALITY CONTROL CHECK TO MAKE SURE THAT YOUR BLOOD GLUCOSE MONITOR AND THE NOVA MAX GLUCOSE TEST STRIPS ARE WORKING CORRECTLY. DO A CONTROL SOLUTION TEST: EACH TIME YOU OPEN A NEW VIAL OF TEST STRIPS. NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER CONTINUED TO ADMINISTER INSULIN BASED ON MULTIPLE HIGHER THAN EXPECTED READINGS ON THEIR BLOOD GLUCOSE METER THROUGHOUT THE DAY AND EVENING. THE CONSUMER SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT, WHICH DID REQUIRE MEDICAL INTERVENTION. DURING THE CALL INTO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT HAVE ANY CONTROL SOLUTION FOR TESTING HER TEST STRIPS BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40799 NOVA MAX GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020213212

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention