BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 2201067 · Received July 1, 2011

    Report

    Report Number
    1826988-2011-00388
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER BREEZE2 METER AND RECEIVED A READING OF 297 MG/DL. HER GLUCOSE WAS RETESTED USING ANOTHER METER AND THAT READING WAS 119 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. CONTROL SOLUTION WAS SENT TO THE CUSTOMER FOR FURTHER TROUBLESHOOTING. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 NBW BAYER HEALTHCARE LLC 1440D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK