BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE 2

    MDR report key: 1935126 · Received December 6, 2010

    Report

    Report Number
    1826988-2010-00811
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER ALLEGED THAT HE RECEIVED A BLOOD GLUCOSE READING OF 321 MG/DL USING HIS BREEZE2 METER. THE METER IN QUESTION SHOULD HAVE THE UNITS OF MEASURE LOCKED IN MMOL/L. NO ADVERSE EVENTS WERE ALLEGED. THE METER IS TO BE RETURNED FOR EVALUATION. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE 2 NBW BAYER HEALTHCARE LLC 6118C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK