BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LATITUDE DIABETES MANAGEMENT SYSTEM

    MDR report key: 532429 · Received March 5, 2004

    Report

    Report Number
    2243072-2004-00140
    Event Type
    Other
    Date Received
    March 5, 2004
    Date of Event
    February 7, 2004
    Report Date
    March 4, 2004
    Manufacturer
    BECTON DICKINSON
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER CALLED TO REPORT METER GIVING INACCURATE READINGS, WHEN COOMPARED TO THEIR OTHER METER. ANALYSIS RUN ON CLARK ERROR GRID USING COMPETITIVE READINGS (125, 211, 142, 280) AS REF. POINT VS. BD READINGS 353, 389, 346, 548 YIELDED DATA POINTS IN THE C RANGE OF THE GRID, OUTSIDE ACCEPTABLE LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LATITUDE DIABETES MANAGEMENT SYSTEM BD TEST STRIPS CFR BECTON DICKINSON NA 2057336

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other