BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TS

    MDR report key: 2222339 · Received July 15, 2011

    Report

    Report Number
    1826988-2011-00404
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALL ENDED BEFORE THE CUSTOMER'S PERSONAL INFO OR PRODUCT INFO COULD BE OBTAINED. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE W/O THE METER INFO.

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING HIS CONTOUR TS METER AND REC'D READINGS OF 152 AND 154 MG/DL. HE RETESTED USING ANOTHER METER AND REC'D A READING OF 86 MG/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 CUSTOMER DECLINED TO TROUBLESHOOT OR PROVIDE ADD'L INFO BEFORE ENDING THE CALL. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TS NBW BAYER HEALTHCARE LLC NOT PROVIDED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK