BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2 TEST STRIPS

    MDR report key: 2142655 · Received June 21, 2011

    Report

    Report Number
    1826988-2011-00332
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER PERFORMED A CONTROL TEST USING HIS BREEZE2 METER AND RECEIVED A RESULT OF 180 MG/DL. THE NORMAL CONTROL RANGE WAS 90-124 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 TEST STRIPS NBW BAYER HEALTHCARE, LLC NOT PROVIDED 1A5914AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK