BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1821578 · Received August 27, 2010

    Report

    Report Number
    1826988-2010-00582
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K060470
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT HIS BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL AND THAT HE HAD RECEIVED HIGH, OUT OF RANGE CONTROL TEST RESULTS. WHILE TROUBLESHOOTING, HE PERFORMED 2 CONTROL TESTS AND RECEIVED RESULTS OF 193 AND 212 MG/DL. THE NORMAL CONTROL RANGE WAS 110-152 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER USED THE LAST OF THE TEST STRIPS WHILE TROUBLESHOOTING, SO NO PRODUCT WILL BE RETURNED. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE LLC 7151A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK