BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TS TEST STRIPS (50)

    MDR report key: 1030395 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00419
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 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 STATED THAT SHE TESTED HER BLOOD GLUCOSE USING HER CONTOUR METER AND ANOTHER METER. THE CONTOUR READ 501 MG/DL, WHILE THE OTHER METER READ 91 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. WHILE TROUBLESHOOTING, THE CUSTOMER PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 218 MG/DL. THE NORMAL CONTROL RANGE WAS 99-136 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TS TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 1820 7LD3E07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK