BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1070382 · Received July 3, 2008

    Report

    Report Number
    3004193489-2008-00481
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 9, 2008
    Report Date
    July 3, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Product Problem
    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 155 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED ANOTHER TEST USING THE SAME METER AND STRIPS GETTING A RESULT OF 165 MG/DL. THEN CONSUMER USED THE SAME TEST STRIPS WITH ANOTHER NOVA METER GETTING BACK TO BACK RESULT OF 452 MG/DL AND 370 MG/DL. THE DIFFERENCE IN THE READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020207213

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK