BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 795763 · Received December 22, 2004

    Report

    Report Number
    2243072-2004-00732
    Event Type
    Other
    Date Received
    December 22, 2004
    Date of Event
    November 27, 2004
    Report Date
    December 22, 2004
    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 INCONSISTENT READINGS WITH HER BD LOGIC METER. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVERAGE READING (373) AS REF POINT VS. BD READINGS (200, 545) YIELDED DATA POINTS IN THE C ZONE OF THE GRID, OUTSIDE 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 4064103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other