BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1031428 · Received April 18, 2008

    Report

    Report Number
    3004193489-2008-00351
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 18, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 45 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED ANOTHER FOUR TESTS USING THE SAME METER AND STRIPS GETTING THE FOLLOWING RESULTS OF 105 MG/DL, 45 MG/DL, 94 MG/DL, AND 115 MG/DL. THESE RESULTS WERE TAKEN FOUR DAYS AFTER A BRIEF HOSPITALIZATION FOR THE FLU. IT WAS DISCOVERED THE CONSUMER IS STORING THE TEST STRIPS IN A KITCHEN HALLWAY AGAINST NOVA'S DIRECTIONS, WHICH IT MAY COMPROMISE THE INTEGRITY OF THE TEST STRIPS. 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 N7064179

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK