BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1811074 · Received August 11, 2010

    Report

    Report Number
    1826988-2010-00526
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    LFR
    PMA / PMN Number
    K060470
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER CONTACTED CUSTOMER SERVICE ABOUT HIS CONTOUR LINK METER. HE ALLEGED HIS BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL. WHILE TROUBLESHOOTING, THE CUSTOMER PERFORMED A CONTROL TEST USING HIGH CONTROL SOLUTION. THE CONTROL RESULT WAS 489 MG/DL. THE HIGH CONTROL RANGE WAS 309 - 426 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. CUSTOMER SERVICE WAS ADVISED TO HAVE THE CUSTOMER RETURN HIS TEST STRIPS FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS LFR BAYER HEALTHCARE, LLC NOT PROVIDED 9HC3D01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK