BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1883369 · Received July 18, 2010

    Report

    Report Number
    1826988-2010-00372
    Event Type
    Malfunction
    Date Received
    July 18, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 25, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    LFR
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER TWO CONTOUR METERS. ONE METER READ 327 MG/DL, WHILE THE OTHER READ 137 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER RETURNED THE TEST STRIPS FOR EVALUATION. REPLACEMENT STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (50) LFR BAYER HEALTHCARE LLC 7080G 8FC3C08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK