BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 1200373 · Received October 10, 2008

    Report

    Report Number
    3004193489-2008-00591
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 10, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 HIGH READING AND TREATED HIMSELF FOR A HIGH READING AND SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT WHICH REQUIRED MEDICAL INTERVENTION. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST HIS TEST STIRPS BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE. IT WAS ALSO REVEALED THAT THE CONSUMER IMPROPERLY STORES HIS TEST STRIPS. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF THE CALL. THE METER 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 CORPORATION NA 1020208071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention