BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3070059 · Received April 22, 2013

    Report

    Report Number
    1826988-2013-00167
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER USED THE LOW AND HIGH CONTROL SOLUTIONS AND RECEIVED LOW OUT OF RANGE READINGS OF 18 AND 48 MG/DL, RESPECTIVELY, ON HER CONTOUR METER. WHILE CHECKING THE MEMORY OF THE METER IT WAS DISCOVERED THAT THE READINGS WERE NOT AUTOMATICALLY MARKED AS CONTROL TESTS, WHICH WILL BE DISPLAYED AS A BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE CONTROL SOLUTION HAD ALREADY BEEN DISCARDED SO PRODUCT INFORMATION WAS NOT PROVIDED. PRODUCT WILL NOT BE RETURNED FOR EVALUATION. NEW METER, STRIPS AND CONTROL WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172596 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 7151H

    Patients

    Seq Age Sex Outcome Treatment
    1