BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1310231 · Received December 12, 2008

    Report

    Report Number
    1826988-2008-01473
    Event Type
    Malfunction
    Date Received
    December 12, 2008
    Date of Event
    December 8, 2008
    Report Date
    December 8, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE RECEIVED CONTROL TEST RESULTS OF 220, 229, AND 227 MG/DL. WHILE TROUBLESHOOTING, SHE PERFORMED 2 MORE CONTROL TESTS AND RECEIVED RESULTS OF 214 AND 228 MG/DL. THE NORMAL CONTROL RANGE WAS 105-144 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. THE CUSTOMER ALSO INSISTED THE METER BE REPLACED. REPLACEMENT PRODUCTS 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 7080G 8BC3D10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK