BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TS TEST STRIPS (50)

    MDR report key: 1120989 · Received August 13, 2008

    Report

    Report Number
    1826988-2008-00861
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE OPENED A NEW CARTON OF TEST STRIPS AND FOUND THE CAP OPEN ON THE BOTTLE OF STRIPS. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL, AS EXPOSURE TO MOISTURE/HUMIDITY 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 TS TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 1820 7LD3E07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK