BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1821607 · Received August 27, 2010

    Report

    Report Number
    1826988-2010-00589
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ENDED THE CALL BEFORE METER INFORMATION COULD BE OBTAINED. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURER DATE OR 510K NUMBER WITHOUT PRODUCT INFORMATION. ATTEMPTS TO CALL THE CUSTOMER BACK WERE NOT SUCCESSFUL.

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING HIS 2 CONTOUR METERS AND RECEIVED READINGS OF 297 AND 125 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 ENDED THE CALL BEFORE ANY ADDITIONAL INFORMATION COULD BE OBTAINED. ATTEMPTS TO CONTACT THE CUSTOMER AFTER THE INITIAL CALL WERE NOT SUCCESSFUL. NO PRODUCT WILL BE RETURNED.

    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