BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3982707 · Received July 22, 2014

    Report

    Report Number
    1826988-2014-00243
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER RECEIVED A BLOOD TEST RESULT OF 49MG/DL ON THE CONTOUR NEXT LINK METER AND THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST. WHEN ACCESSING THE METER'S MEMORY, THE READING WILL BE VIEWED AS A CONTROL TESTING INSTEAD OF A BLOOD TEST. NO ADVERSE EVEN WAS ALLEGED. THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429307 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 4AFEC02

    Patients

    Seq Age Sex Outcome Treatment
    1