BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1157569 · Received September 2, 2008

    Report

    Report Number
    1826988-2008-00946
    Event Type
    Malfunction
    Date Received
    September 2, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ADVOCATE CALLED ON BEHALF OF THE CANADIAN CUSTOMER. HE STATED THAT SHE TESTED HER BLOOD GLUCOSE USING HER CONTOUR LINK METER, AND RECEIVED READINGS OF 1.7 MMOL/L (31 MG/DL) AND 1.2 MMOL/L (22 MG/DL). THE CUSTOMER'S GLUCOSE WAS RETESTED AT THE HOSPITAL WITHIN 10 MINUTES, AND HER READING WAS AROUND 15 MMOL/L (270 MG/DL), USING THE HOSPITAL METER. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS AND METER ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC. NOT PROVIDED 7LC3D07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK