BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1190666 · Received October 3, 2008

    Report

    Report Number
    1826988-2008-01130
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    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 STATED THAT SHE TESTED HER BLOOD GLUCOSE USING HER CONTOUR METER AND RECEIVED READINGS OF 420 MG/DL AND A READING HIGHER THAN 500 MG/DL. SHE RETESTED USING ANOTHER CONTOUR METER AND RECEIVED READINGS OF 190 AND 191 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. TROUBLESHOOTING WAS NOT POSSIBLE SINCE THE CUSTOMER DID NOT HAVE CONTROL SOLUTION. CONTROL SOLUTION WAS SENT TO THE CUSTOMER. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    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