BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 3090479 · Received May 2, 2013

    Report

    Report Number
    1826988-2013-00196
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 13, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OF THE TWO BOTTLES OF STRIPS RECEIVED AND TESTED IN QA GAVE AN AVERAGE OF 2MG/DL LOW, OUT OF SPEC READINGS WHEN TESTED WITH BLOOD, BUT GAVE SATISFACTORY PERFORMANCE WHEN TESTED WITH CONTROL. THE RETENTION LOT GAVE SATISFACTORY RESULTS ON BOTH BLOOD AND CONTROL. HIGH RESULTS WERE NOT CONFIRMED.

    Description of Event or Problem · 1

    THE ADVOCATE STATED HIS WIFE WAS INCOHERENT, SO HE CALLED AN AMBULANCE TO TAKE HER TO THE HOSPITAL. HER BLOOD GLUCOSE WAS TESTED ON HER CONTOUR METER AND THE PARAMEDIC'S CONTOUR. THE READINGS WERE 188 AND 35MG/DL, RESPECTIVELY. ADDITIONAL INFORMATION ABOUT THE EVENT WAS NOT PROVIDED. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" OR "E" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191771 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7097C 1EC3A01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization