BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    MDR report key: 5316323 · Received September 30, 2004

    Report

    Report Number
    2243072-2004-00597
    Event Type
    Other
    Date Received
    September 30, 2004
    Date of Event
    August 30, 2004
    Report Date
    September 30, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 HIS METER IS NOT SHOWING ACCURATE READINGS. ANALYSIS RUN ON CLARK ERROR GRID USING MEAN AVG. READING (174) AS REF. POINT VS. BD READINGS (57, 242, 223) 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 3064079

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK