BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE2 TEST STRIPS

    MDR report key: 1884413 · Received October 25, 2010

    Report

    Report Number
    1826988-2010-00717
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED USING HER BREEZE2 METER AND THE READING WAS 80 MG/DL. THE CUSTOMER WAS NOT FEELING WELL, SO HER BLOOD GLUCOSE WAS RETESTED USING ANOTHER METER. THE OTHER METER READ 40 MG/DL. THE CUSTOMER WAS GIVEN SOMETHING TO EAT AND DRINK IN ORDER TO RAISE HER BLOOD GLUCOSE. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE ADVOCATE WAS ADVISED TO RETURN THE TEST STRIPS FOR EVAL. REPLACEMENT STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 TEST STRIPS NBW BAYER HEALTHCARE, LLC 1467 1A5771AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention