BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1070675 · Received July 3, 2008

    Report

    Report Number
    3004193489-2008-00493
    Event Type
    Other
    Date Received
    July 3, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 3, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 RECEIVED A RESULT OF 236 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER'S HUSBAND BROUGHT THE CONSUMER TO THE EMERGENCY ROOM BECAUSE SHE WAS NOT FEELING WELL. THE EMERGENCY ROOM TESTED THE CONSUMER USING THEIR UNK BLOOD GLUCOSE METER, GETTING A RESULT OF 34 MG/DL. IT WAS DISCOVERED DURING THIS CALL, THE CONSUMER IS TRANSFERRING HER TEST STRIPS FROM ONE VIAL TO ANOTHER VIAL, WHICH IS AGAINST OUR DIRECTIONS FOR USE. THIS IMPROPER HANDLING OF TEST STRIPS MAY COMPROMISE THE INTEGRITY OF THE TEST STRIPS. THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK