BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1001177 · Received February 15, 2008

    Report

    Report Number
    1826988-2008-00218
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT HE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 177 MG/DL. THE NORMAL CONTROL RANGE WAS 90-135 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 7151A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK