BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1317099 · Received January 9, 2009

    Report

    Report Number
    3004193489-2009-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2009
    Date of Event
    November 24, 2008
    Report Date
    January 9, 2009
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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'S METER WAS NOT SHOWING ALL THE SEGMENTS OF THE TIME OR DATE. DURING THE EVALUATION OF THE DEVICE, IT WAS CONFIRMED THAT THE FIRST AND SECOND DIGIT OF THE BLOOD GLUCOSE RESULT WOULD NOT DISPLAY MAKING THE REPORT A REPORTABLE EVENT. THE METER 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK