BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1024232 · Received March 27, 2008

    Report

    Report Number
    1826988-2008-00332
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 9, 2008
    Report Date
    March 9, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP IN PERFORMING A CONTROL TEST. HE PERFORMED SEVERAL TESTS AND RECEIVED A RESULT OF 259 MG/DL. THE NORMAL CONTROL RANGE WAS 104-143 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER SERVICE REP SUGGESTED THE CUSTOMER RETURN THE TEST STRIPS FOR EVAL. THE OTHER CONTROL TESTS RESULTS HAD BEEN WITHIN THE CONTROL RANGE, SO THE CUSTOMER DECLINED TO RETURN HIS TEST STRIPS.

    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