BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1012915 · Received March 11, 2008

    Report

    Report Number
    1826988-2008-00268
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 221 MG/DL. THE NORMAL CONTROL RANGE WAS 101-140 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DECLINED TROUBLESHOOTING. THE TEST STRIPS AND METER WERE 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 (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7098B 7GC3A05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK