BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1163690 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01030
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BAYER HEALTHCARE LLC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READINGS HAD BEEN LOWER THAN USUAL. SHE TESTED HER GLUCOSE AND RECEIVED READINGS OF 32 AND 52 MG/DL USING HER CONTOUR METER. SHE RETESTED USING ANOTHER METER AND RECEIVED READINGS OF 155 AND 240 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. 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 TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC. NOT PROVIDED 7KC3C08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK