BEUDAMED
    FDA Adverse Event Other Summary report: N

    BDE PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 5302862 · Received September 17, 2004

    Report

    Report Number
    2243072-2004-00561
    Event Type
    Other
    Date Received
    September 17, 2004
    Date of Event
    August 17, 2004
    Report Date
    September 17, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING PRODUCT RETURN TO CONDUCT QUALITY INVESTIGATION.

    Description of Event or Problem · 1

    CONSUMER REPORTS HAVING LOW READINGS WITH HER PLINK METER. ANALYSIS RUN ON CLARK ERROR GRID USING COMPETITIVE READING (179) AS REF POINTS VS BD READINGS (32) 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 BDE PARADIGM LINK BLOOD GLUCOSE MONITOR BD TEST STRIPS NBW BECTON DICKINSON NA 4064077

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other