BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR LINK

    MDR report key: 4915398 · Received July 15, 2015

    Report

    Report Number
    1826988-2015-00343
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    February 2, 2015
    Report Date
    June 24, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS.

    Additional Manufacturer Narrative · 1

    THE RETURNED METER WAS EVALUATED AND CONFIRMED FOR THE PROBLEM OF STORING RESULTS TO THE MEMORY DUE TO A LOW BATTERY CONDITION. ONCE THE BATTERIES WERE REPLACED RESULTS WERE STORED IN THE MEMORY.

    Description of Event or Problem · 1

    (B)(6) CUSTOMER STATED SOME OF HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR LINK. NO ADVERSE EVENT ALLEGED. THE CUSTOMER WAS ASKED TO RETURN THE METER FOR INVESTIGATION. A REPLACEMENT METER WAS SENT TO HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460998 CONTOUR LINK BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 7778

    Patients

    Seq Age Sex Outcome Treatment
    1