BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1033316 · Received January 15, 2008

    Report

    Report Number
    3004193489-2008-00057
    Event Type
    Malfunction
    Date Received
    January 15, 2008
    Date of Event
    December 18, 2007
    Report Date
    January 15, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    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 24 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY TESTED AGAIN USING THE SAME TEST STRIPS AND THE SAME METER GETTING THE FOLLOWING RESULTS OF 75 MG/DL AND 201 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 6064270

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK