BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 1133167 · Received August 22, 2008

    Report

    Report Number
    3004193489-2008-00527
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 9, 2008
    Report Date
    August 22, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER'S BLOOD GLUCOSE METER SWITCHED THE UNITS OF MEASURE FROM MG/DL TO MMOL/DL. THE METER IN QUESTION WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LOGIC BLOOD GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK