BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 694651 · Received March 31, 2006

    Report

    Report Number
    1826988-2006-00315
    Event Type
    Malfunction
    Date Received
    March 31, 2006
    Date of Event
    March 20, 2006
    Report Date
    March 20, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE TOOK 4 BLOOD GLUCOSE TEST BACK TO BACK AND RECEIVED THE FOLLOWING RESULTS: 95, 240, 227, AND 208 MG/DL. THE DIFFERENCE BETWEEN THE FIRST TWO READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE METER AND STRIPS ARE TO BE RETURNED FOR EVALUATION, AND A REPLACEMENT METER ANS STRIPS WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN