BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 794323 · Received December 5, 2006

    Report

    Report Number
    2243072-2006-00431
    Event Type
    Other
    Date Received
    December 5, 2006
    Date of Event
    November 6, 2006
    Report Date
    December 4, 2006
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    PMA / PMN Number
    k041478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING PRODUCT RETURN TO CONDUCT QUALITY INVESTIGATION.

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT ERRATIC READINGS FROM HIS METER. ANALYSIS RUN ON CONSENSUS ERROR GRID USING MEAN READING (136) AS REFERENCE POINT VS. BD READINGS (33, 122, 253) YIELDED DATA POINTS IN THE C RANGE OF THE GRID, OUTSIDE OF 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 6064205

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other