BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 1063725 · Received June 20, 2008

    Report

    Report Number
    3004193489-2008-00483
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 20, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 MULTIPLE HIGH BLOOD GLUCOSE READINGS AND CONTINUED TO BOLUS UNK AMOUNTS OF INSULIN THROUGHOUT THE DAY. SHE SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. IT WAS REVEALED THAT THE CONSUMER IS TRANSFERRING HER TEST STRIPS FROM ONE VIAL TO ANOTHER VIAL AGAINST DIRECTIONS FOR USE AND THIS MAY COMPROMISE THE INTEGRITY OF THE TEST STRIPS. THE CONSUMER WAS ALSO USING THE WRONG NOVA TEST STRIPS. TEST STRIPS 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 6064271

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK