BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 2930123 · Received January 25, 2013

    Report

    Report Number
    1826988-2012-00709
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 26, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER'S BLOOD GLUCOSE READING ON THE BREEZE2 WAS 168MG/DL. HE WAS RE-TESTED ON A DIFFERENT METER AND THE READING WAS 41MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED THE STRIP INFORMATION WAS NOT OBTAINED. . NEW STRIPS AND CONTROL WERE SENT FOR FURTHER TROUBLESHOOTING. PRODUCT WILL NOT BE RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35044 BREEZE2 BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 9570A

    Patients

    Seq Age Sex Outcome Treatment
    1