BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTOUR LINK

    MDR report key: 2265165 · Received September 16, 2011

    Report

    Report Number
    1826988-2011-00545
    Event Type
    Death
    Date Received
    September 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER SERVICE IN THE (B)(6) WAS CONTACTED BY MEDTRONIC AND ADVISED THAT A USER OF ONE OF THEIR PUMPS HAD DIED. THE DEATH IS CONSIDERED A POSSIBLE SUICIDE. PARAMEDICS ADVISED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS VERY LOW UPON THEIR ARRIVAL, BUT NO OTHER DETAILS WERE AVAILABLE. THE PUMP RESULTS WERE DOWNLOADED AND SHOW POOR INSULIN CONTROL. BAYER WAS APPROACHED BY A THIRD PARTY REPRESENTING (B)(6) IN ORDER TO DOWNLOAD THE CONTOUR LINK METER RESULTS. NO OTHER INFO IS KNOWN AT THIS TIME. THE CONTOUR LINK METER AND TEST STRIPS (IF AVAILABLE) ARE TO BE RETURNED TO THE US FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR LINK NBW BAYER HEALTHCARE, LLC NOT PROVIDED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death