BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1611925 · Received February 9, 2010

    Report

    Report Number
    1826988-2010-00083
    Event Type
    Malfunction
    Date Received
    February 9, 2010
    Date of Event
    January 28, 2010
    Report Date
    January 28, 2010
    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 ALLEGED THAT HE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 459 MG/DL. WHILE TROUBLESHOOTING, HE PERFORMED CONTROL TESTS AND RECEIVED RESULTS OF 431 AND 437 MG/DL. THE NORMAL CONTROL RANGE WAS 110-151 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 TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7080G 9AC3B01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK