BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1012906 · Received March 11, 2008

    Report

    Report Number
    1826988-2008-00260
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 18, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED RESULTS OF 475 AND 480 MG/DL. THE NORMAL CONTROL RANGE WAS 100-138 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TESTS TRIPS 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 7098B 7DC3D12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK