BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2072624 · Received April 25, 2011

    Report

    Report Number
    1826988-2011-00192
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE (B)(6) CUSTOMER TESTED HER BLOOD GLUCOSE USING HER CONTOUR LINK METER AND RECEIVED READINGS OF 1.9, "LO" AND 1.2 MMOL/L. SHE RETESTED USING HER CONTOUR AND RECEIVED A READING OF 7.8 MMOL/L. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE ADVOCATE WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT STRIPS AND A NEW LINK METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC NOT PROVIDED 0LC3B31

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK