BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE2

    MDR report key: 2062664 · Received April 11, 2011

    Report

    Report Number
    1826988-2011-00193
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 12, 2011
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALL ENDED BEFORE THE METER SERIAL NUMBER COULD BE OBTAINED. CUSTOMER SERVICE ATTEMPTED TO CONTACT THE CUSTOMER OR ADVOCATE AFTER THE INITIAL CALL, BUT THE ADVOCATE STATED IT WAS NOT A GOOD TIME TO TALK. IT'S NOT POSSIBLE TO DETERMINED THE MANUFACTURE DATE WITHOUT THE SERIAL NUMBER.

    Description of Event or Problem · 1

    THE ADVOCATE CALLED REGARDING THE CUSTOMER'S BREEZE2 METER. SHE STATED THE SCREEN WOULD GO BLANK AFTER A TEST STRIP WAS PRESENTED AND THE CUSTOMER WAS UNABLE TO TEST HIS BLOOD GLUCOSE. A WEEK BEFORE CALLING, THE CUSTOMER WAS TAKEN TO THE HOSPITAL BECAUSE HE WAS UNABLE TO GET A READING. THE HOSPITAL TESTED HIS BLOOD GLUCOSE AND REC'D A READING OVER 500 MG/DL. THE ADVOCATE DID NOT PROVIDE ANY ADDITIONAL INFORMATION ABOUT THE EVENT. A LOCAL PHARMACY REPLACED THE CUSTOMER'S METER. THE PHARMACY IS TO RETURN THE OTHER METER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 NBW BAYER HEALTHCARE, LLC NOT PROVIDED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization