BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1001149 · Received February 15, 2008

    Report

    Report Number
    1826988-2008-00181
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 28, 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 STATED THAT HIS BLOOD GLUCOSE READINGS HAD BEEN HIGHER WHEN TESTING WITH HIS CONTOUR METER. HE PERFORMED CONTROL TESTS WHILE TROUBLESHOOTING AND RECEIVED A RESULT OF 221 MG/DL. THE NORMAL CONTROL RANGE WAS 103-143 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE 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 NOT PROVIDED 7JC3A01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK