BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1900001 · Received November 8, 2010

    Report

    Report Number
    1826988-2010-00761
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HIS CONTOUR METER. SHE ALLEGED THAT HER BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL. THE CUSTOMER PERFORMED CONTROL TESTS AND RECEIVED RESULTS OF 190 AND 201 MG/DL. THE NORMAL CONTROL RANGE WAS 108-148 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. CUSTOMER SERVICE ADVISED THE CUSTOMER TO RETURN THE TEST STRIPS FOR EVAL, BUT SHE REFUSED. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC 9545C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK