BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 475350 · Received July 29, 2003

    Report

    Report Number
    2243072-2003-00023
    Event Type
    Other
    Date Received
    July 29, 2003
    Date of Event
    May 1, 2003
    Report Date
    July 28, 2003
    Manufacturer
    BECTON DICKINSON
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS INACCURATE READINGS FROM BD TEST STRIPS. READINGS WERE 350, 110, 139. ANALYSIS RUN USING CLARKE ERROR GRID (MEAN AVERAGE 200 AS REF. POINT) INDICATES 350 READING IN -C ZONE OF THE GRID, OUTSIDE ACCEPTABLE RANGE. POSSIBLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LOGIC BLOOD GLUCOSE MONITOR BG TEST STRIPS CFR BECTON DICKINSON NA 2064308 (STRIPS)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other