BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1163647 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-00993
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT HE PERFORMED CONTROL TESTS AND RECEIVED 2 RESULTS OF "LO". THE NORMAL CONTROL RANGE WAS 106-147 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. CUSTOMER SERVICE ATTEMPTED TO FURTHER TROUBLESHOOT THE CONTOUR SYSTEM, BUT THE CUSTOMER DECLINED. THE TEST STRIPS WERE RETURNED FOR EVALUATION. REPLACEMENTS 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 7KC3D02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK