BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1884183 · Received October 15, 2010

    Report

    Report Number
    3004193489-2010-00232
    Event Type
    Other
    Date Received
    October 15, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 15, 2010
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 RECEIVED A RESULT OF 242 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER ADMINISTERED AN UNK AMOUNT OF INSULIN BASED ON THAT RESULT. SUBSEQUENTLY, THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING EMERGENT FOOD INTAKE TO RAISE HER BLOOD SUGAR LEVEL. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE 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 EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020210202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention