BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 744659 · Received June 16, 2005

    Report

    Report Number
    2243072-2005-00216
    Event Type
    Other
    Date Received
    June 16, 2005
    Date of Event
    May 19, 2005
    Report Date
    June 16, 2005
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING PRODUCT RETURN TO CONDUCT QUALITY INVESTIGATION.

    Description of Event or Problem · 1

    CUSOMTER CALLED TO REPORT ACCURACY ISSUE WITH HER METER. HAD MER METER TESTED AGAINST A LAB READING. ANALYSIS RUN ON CLARK ERROR GRID USING LAB READINGS (61) AS REFERENCE POINT VS. BD READINGS (91) YIELDED SOME DATA PONTS IN THE D RANGE OF THE GRID, OUTSIDE ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK BLOOD GLUCOSE MONITOR BD TEST STRIPS NBW BECTON DICKINSON NA 4064278

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other