BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT LINK

    MDR report key: 2912832 · Received January 14, 2013

    Report

    Report Number
    1826988-2012-00697
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REAGENT STRIP INFORMATION WAS NOT INITIALLY PROVIDED BUT THEY WERE RETURNED FOR EVALUATION: LOT# 2EFEC04, EXPIRATION DATE 05/31/2014. MANUFACTURE DATE 05/01/2012.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: ADDRESS AND PHONE WERE NOT PROVIDED.

    Description of Event or Problem · 1

    THE ADVOCATE STATED HER SON RECEIVED A BLOOD GLUCOSE READING OF 30MG/DL ON HIS CONTOUR NEXT LINK METER, RE-TESTED ON A DIFFERENT METER AND RECEIVED 200MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE ADVOCATE DECLINED TO TROUBLESHOOT AND PROVIDED ONLY THE METER INFORMATION. CUSTOMER STRIPS ARE TO BE RETURNED FOR EVALUATION. METER AND STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20417 CONTOUR NEXT LINK BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 6203

    Patients

    Seq Age Sex Outcome Treatment
    1