BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 2842330 · Received November 21, 2012

    Report

    Report Number
    1826988-2012-00610
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL FROM A FIRE DEPARTMENT STATED THEY RAN A BLOOD GLUCOSE TEST ON A PATIENT WITH THE DEPARTMENT'S CONTOUR METER AND THE READING WAS 161MG/DL. THE PATIENT WAS NOT FEELING WELL SO THEY TOOK HIM TO THE HOSPITAL. A BLOOD GLUCOSE TEST WAS RUN ON THE HOSPITAL METER AND THE READING WAS 30MG/DL. FURTHER INFORMATION ABOUT THE EVENT WAS NOT PROVIDED. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "E" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 2CC3D03

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization