BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1063717 · Received June 20, 2008

    Report

    Report Number
    3004193489-2008-00461
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 13, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF "HI" (GREATER THAN 600 MG/DL) ON THEIR BLOOD GLUCOSE METER. THE CONSUMER DID NOT BELIEVE THE RESULT TO BE CORRECT, SO SHE TESTED AGAIN ON HER OTHER NOVA LOGIC METER AND BD TEST STRIPS GETTING A RESULT OF 238 MG/DL WHICH SHE BELIEVED TO BE A CORRECT READING. IT WAS DISCOVERED DURING THIS CALL, THE CONSUMER IS TRANSFERRING TEST STRIPS FROM ONE VIAL TO ANOTHER WHICH MAY HAVE COMPROMISED THE INTEGRITY OF THE TEST STRIPS. THE CONSUMER IS ALSO STORING THE METER AND TEST STRIPS IN AN AREA WHICH MAY ALSO COMPROMISE THE TEST STRIPS AND BOTH ISSUES ARE AGAINST OUR DIRECTIONS FOR USE. THE DIFFERENCE IN THE READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE METER AND 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 CORP. NA 1020207184

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK