BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 1083550 · Received July 25, 2008

    Report

    Report Number
    3004193489-2008-00521
    Event Type
    Other
    Date Received
    July 25, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 25, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 RECEIVED A RESULT OF 367 MG/DL ON THEIR BLOOD GLUCOSE METER AT 2:00 PM. THE CONSUMER ADMINISTERED 3 UNITS OF INSULIN BASED ON THAT READING. THE CONSUMER SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTIONS TEST HER TEST AS INSTRUCTED IN OUR DIRECTIONS FOR USE. CONSUMER EDUCATED ON THESE DIRECTIONS FOR USE AT TIME OF CALL. THE METER AND THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020208072

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK