BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1362477 · Received February 4, 2009

    Report

    Report Number
    1826988-2009-00087
    Event Type
    Malfunction
    Date Received
    February 4, 2009
    Date of Event
    January 23, 2009
    Report Date
    January 23, 2009
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A CONTROL TEST RESULT THAT WAS 35 MG/DL. THE CONTROL LIMITS ARE 103 - 142 MG/DL. THE CUSTOMER REFUSED TO RETURN PRODUCT. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK