BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1884663 · Received October 25, 2010

    Report

    Report Number
    1826988-2010-00716
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVOCATE ENDED THE CALL BEFORE THE CUSTOMER'S ADDRESS OR PRODUCT INFO COULD BE OBTAINED. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE OR 510K NUMBER WITHOUT THE PRODUCT INFO. THE CUSTOMER SERVICE AGENT CALLED THE ADVOCATE BACK AFTER SHE ENDED THE CALL, BUT SHE STATED SHE DID NOT HAVE TIME TO TALK.

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER TESTED HER BLOOD GLUCOSE AND REC'D A READING OF 303 MG/DL USING HER CONTOUR METER. SHE RETESTED USING ANOTHER CONTOUR METER AND REC'D A READING OF 104 MG/DL. 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 ADVOCATE ENDED THE CALL BEFORE ANY PRODUCT INFO COULD BE OBTAINED. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK