BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE2

    MDR report key: 4140735 · Received October 3, 2014

    Report

    Report Number
    1826988-2014-00346
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    AN ADVOCATE STATED THE CUSTOMER BECAME UNRESPONSIVE. HIS BLOOD RESULT ON THE BREEZE2 WAS 78MG/DL. AN AMBULANCE WAS CALLED AND THE EMT RETESTED THE CUSTOMER ON A DIFFERENT METER WITH A READING OF 49MG/DL. THE CUSTOMER WAS GIVEN SUGAR WATER THREE TIMES AND WAS FEELING BETTER AFTER THREE HOURS. THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATON. A NEW KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620942 BREEZE2 BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 9674A 1A6539AA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention