BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2593410 · Received May 25, 2012

    Report

    Report Number
    1826988-2012-00274
    Event Type
    Malfunction
    Date Received
    May 25, 2012
    Date of Event
    April 15, 2012
    Report Date
    May 4, 2012
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BREEZE2 TEST STRIPS WERE ALSO INVOLVED: MODEL NOT PROVIDED, LOT # 1A6060AA, EXP. DATE 02/28/2013, DEVICE MANUFACTURE DATE 08/2011, 510(K) K062347.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 500 MG/DL FROM HER CONTOUR METER. SHE RETESTED USING HER BREEZE2 METER AND RECEIVED A READING OF 78 MG/DL. 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. CONTROL SOLUTION WAS SENT TO THE CUSTOMER FOR FURTHER TROUBLESHOOTING. NO PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC 7098C 2BC3F05A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK