BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2213843 · Received August 4, 2011

    Report

    Report Number
    1826988-2011-00445
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER TESTED HER BLOOD GLUCOSE AND RECEIVED A READING OF 487 MG/DL USING HER CONTOUR METER. SHE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 136 MG/DL. ANOTHER TEST USING THE CONTOUR METER GAVE A RESULT OF 566 MG/DL, WHILE THE OTHER METER READ 114 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" AND "D" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST 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 NBW BAYER HEALTHCARE, LLC 7080G 0LC3C11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK