BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (100)

    MDR report key: 1071495 · Received July 2, 2008

    Report

    Report Number
    1826988-2008-00743
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 18, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE OPENED A CARTON CONTAINING 2 BOTTLES OF TEST STRIPS AND FOUND THE CAPS OPEN ON BOTH BOTTLES. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED, AS EXPOSURE TO MOISTURE CAN CAUSE HIGH TEST RESULTS. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (100) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080 7KC3D01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK