BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1031899 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00416
    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 CALLED FOR HELP WITH HER NEW CONTOUR METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED RESULTS OF 23 MG/DL AND "LO." THE NORMAL CONTROL RANGE WAS 103-142 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. CUSTOMER SVC RECOMMENDED THAT THE CUSTOMER RETURN HER TEST STRIPS FOR EVAL, BUT SHE INSISTED THAT SHE WOULD RETURN HER PRODUCTS TO HER SUPPLY CO.

    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