BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 1573663 · Received December 18, 2009

    Report

    Report Number
    1826988-2009-01118
    Event Type
    Malfunction
    Date Received
    December 18, 2009
    Date of Event
    December 5, 2009
    Report Date
    December 5, 2009
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT HE PERFORMED BLOOD GLUCOSE TESTS USING 2 BREEZE2 METERS AND RECEIVED READINGS OF 140, 350 AND 269 MG/DL. THE CUSTOMER DID NOT HAVE TIME TO CHECK THE METER MEMORIES DURING THE CALL, SO IT WAS NOT POSSIBLE TO DETERMINE WHICH READING CAME FROM WHICH METER. THE DIFFERENCE BETWEEN THE 140 AND 350 MG/DL READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. CUSTOMER SERVICE ATTEMPTED TO CONTACT THE CUSTOMER TWICE AFTER THE INITIAL CALL, BUT THE INDIVIDUAL THAT ANSWERED DISCONNECTED THE CALL. NO PRODUCT WILL BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK