BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 2479606 · Received February 27, 2012

    Report

    Report Number
    3004193489-2012-00010
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 24, 2012
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER'S BLOOD GLUCOSE METER SWITCHED UNITS OF MEASURE FROM MG/DL TO MMOL/DL. THE METER 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 CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK