BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR NEXT

    MDR report key: 3162222 · Received June 11, 2013

    Report

    Report Number
    1826988-2013-00287
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A (B)(6) DOCTOR REPORTED THAT ONE OF HIS PATIENTS RECEIVED A BLOOD GLUCOSE READING OF 6.1MMOL/L ON THE CONTOUR XT, TOOK INSULIN ACCORDINGLY AND LOST CONSCIOUSNESS. NO ADDITIONAL DETAILS WERE PROVIDED REGARDING THE INCIDENT. IT WAS ASKED THAT THE TEST STRIPS BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262034 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 2FFEC04

    Patients

    Seq Age Sex Outcome Treatment
    1