BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1031903 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00412
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 240 MG/DL. THE NORMAL CONTROL RANGE WAS 100-138 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DID NOT HAVE ANY TEST STRIPS LEFT, SO NO PRODUCT WILL BE RETURNED FOR EVAL.

    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