BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR NEXT

    MDR report key: 4102851 · Received September 19, 2014

    Report

    Report Number
    1826988-2014-00322
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    WHEN ACCESSING THE MEMORY OF THE CUSTOMER'S METER, THE ALLEGED READINGS OF 220 AND 45MG/DL WERE NOT FOUND. CORRECTION: NAME OF THE METER USED BY CUSTOMER WAS CONTOUR NEXT, NOT CONTOUR XT.

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 220MG/DL ON THE CONTOUR XT, TOOK INSULIN AND AN HOUR LATER HAD HYPOGLYCEMIC SYMPTOMS. SHE RETESTED AND HER BLOOD GLUCOSE WAS 45MG/DL. DETAILS REGARDING THE EVENT WERE NOT PROVIDED. THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION. THE CUSTOMER WAS PROVIDED A NEW METER AND TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584050 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 4EFEF04

    Patients

    Seq Age Sex Outcome Treatment
    1