BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1012718 · Received March 11, 2008

    Report

    Report Number
    3004193489-2008-00286
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 11, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 43 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED ANOTHER TEST USING THE SAME METER, AND A DIFFERENT NOVA BD TEST STRIPS GETTING A RESULT OF 125 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 CORPORATION NA 606272

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK