BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TS TEST STRIPS (50)

    MDR report key: 1163652 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01001
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER TESTED HIS BLOOD GLUCOSE AND RECEIVED A READING OF 448 MG/DL USING HIS CONTOUR TS METER. HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 179 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 SHOWED THE CONTOUR SYSTEM TO BE OPERATING AS DESIGNED, BUT THE TEST STRIPS ARE TO BE RETUNED 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 7LD3E03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK