BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR XT

    MDR report key: 5006575 · Received August 17, 2015

    Report

    Report Number
    1826988-2015-00394
    Event Type
    Malfunction
    Date Received
    August 17, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL# (D4) WAS NOT PROVIDED. IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS.

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER WAS TRYING TO DOWNLOAD READINGS FROM HIS CONTOUR XT AND STATED NONE OF HIS READINGS WERE IN METER MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ASKED TO RETURN THE METER FOR INVESTIGATION. A NEW ONE WAS SENT TO HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543021 CONTOUR XT BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1