BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 2864547 · Received December 6, 2012

    Report

    Report Number
    3004193489-2012-00081
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 24, 2012
    Report Date
    December 5, 2012
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 BLOOD GLUCOSE MONITOR SWITCHED 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 1020212153

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK