BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 2222369 · Received July 15, 2011

    Report

    Report Number
    1826988-2011-00407
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE PRODUCT INFO IN THE EMAIL. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE W/O THE METER INFO.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED CUSTOMER SERVICE VIA EMAIL. SHE COMPARED HER BLOOD GLUCOSE READINGS FROM HER BREEZE2 METER TO THE RESULTS REC'D FROM A LAB TEST. THE BREEZE2 METER READ 178 MG/DL, WHILE THE LAB TEST RESULT WAS 90 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. CUSTOMER SERVICE RESPONDED TO THE CUSTOMER'S EMAIL, BUT THERE HAS BEEN NO FURTHER CONTACT WITH THE CUSTOMER. NO PRODUCT WILL BE RETURNED.

    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