BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 774629 · Received August 28, 2006

    Report

    Report Number
    2243072-2006-00316
    Event Type
    Other
    Date Received
    August 28, 2006
    Date of Event
    August 1, 2006
    Report Date
    August 28, 2006
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING PRODUCT RETURN TO CONDUCT QUALITY INVESTIGATION.

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT READINGS OUT OF RANGE WHEN COMPARING TWO METERS. ANALYSIS RUN ON CONSENSUS ERROR GRID USING COMPETITIVE MEAN READING (103) AS REF. POINT VS. BD READINGS (243, 271) YIELDED DATA POINTS IN THE C ZONE OF THE GRID, OUTSIDE OF ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LOGIC BLOOD GLUCOSE MONITOR BD TEST STRIPS NBW BECTON DICKINSON NA 6064066

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other