BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2121508 · Received May 6, 2011

    Report

    Report Number
    1826988-2011-00227
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS UNABLE TO READ THE PRODUCT INFORMATION ON HER BOTTLE OF TEST STRIPS. W/O THE LOT NUMBER, IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE OR EXPIRATION DATES. IT'S ALSO NOT POSSIBLE TO KNOW THE 510K NUMBER W/O THE PRODUCT INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 148 MG/DL FROM HER CONTOUR METER AND A READING OF 86 MG/DL FROM ANOTHER METER. 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 CUSTOMER WAS ADVISED TO RETURN HER TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS 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 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK