BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 2222606 · Received August 12, 2011

    Report

    Report Number
    3004193489-2011-00075
    Event Type
    Other
    Date Received
    August 12, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 12, 2011
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 FOLLOW-UP 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 HIS BLOOD GLUCOSE RESULT OF 273 MG/DL. THE CONSUMER ADMINISTERED 5.2 UNITS OF INSULIN VIA HIS INSULIN PUMP AND SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING EMERGENT FOOD INTERVENTION TO RAISE HIS BLOOD GLUCOSE LEVEL. 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 WILL BE RETURNED FOR EVALUATION. THE TEST STRIPS WILL NOT BE RETURNED, THEY WERE USED UP BY THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention