BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2142657 · Received June 21, 2011

    Report

    Report Number
    1826988-2011-00329
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A PHARMACIST CALLED ON BEHALF OF A (B)(6) CUSTOMER. HE STATED, THE CUSTOMER COMPARED HER CONTOUR USB READING TO A LAB TEST. THE CONTOUR READ 7.1 MMOL/L, WHILE THE LAB TEST RESULT WAS 2.2 MMOL/L. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE COUNTRY WAS ADVISED TO RETURN THE CUSTOMER'S TEST STRIPS FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC NOT PROVIDED 0AC3D05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK