BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1031900 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00415
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 238 MG/DL. THE NORMAL CONTROL RANGE WAS 99-137 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER HAD TO END THE CALL, SO TROUBLESHOOTING WAS NOT POSSIBLE. THE TEST STRIPS WERE RETURNED FOR EVAL. 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 7HC3C05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK