BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR USB

    MDR report key: 3812185 · Received May 15, 2014

    Report

    Report Number
    1826988-2014-00177
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE PERSONAL INFORMATION OR PRODUCT INFORMATION. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE WITHOUT THE PRODUCT INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED BLOOD GLUCOSE READINGS OF 82, 286, 189MG/DL ON THE CONTOUR NEXT EZ. HE RETESTED ON THE CONTOUR USB AND RECEIVED READINGS OF 91, 252, 193MG/DL. SOME OF THE DIFFERENCES BETWEEN THE READINGS OF THE TWO METERS, FALL IN THE "C" AND "D" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290045 CONTOUR USB BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1