BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 1923559 · Received December 8, 2010

    Report

    Report Number
    1826988-2010-00832
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVOCATE DID NOT HAVE THE CUSTOMER'S PRODUCTS AT THE TIME OF THE CALL SINCE THE CUSTOMER LIVES IN ANOTHER COUNTRY. AS A RESULT, IT WAS NOT POSSIBLE TO OBTAIN PRODUCT INFO OR DETERMINE MANUFACTURER DATE OR THE 510K NUMBER.

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT THE CUSTOMER'S CONTOUR METER WAS GIVING LOWER READINGS BETWEEN 100-150 MG/DL SHE STATED THE CUSTOMER'S GLUCOSE WAS TESTED AT THE HOSPITAL AND THE READINGS WERE 300 MG/DL AND HIGHER. THE CUSTOMER WAS HOSPITALIZED FOR 3 DAYS DUE TO HIGH GLUCOSE. NO OTHER INFO WAS PROVIDED ABOUT THE EVENT. THE CUSTOMER LIVES IN (B)(6), SO IT WAS NOT POSSIBLE TO TROUBLESHOOT HIS CONTOUR SYSTEM. NO PRODUCT WILL BE RETURNED. THE METER WAS REPLACED AT THE ADVOCATE'S INSISTENCE.

    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 Hospitalization