BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 1479233 · Received July 17, 2009

    Report

    Report Number
    1826988-2009-00604
    Event Type
    Malfunction
    Date Received
    July 17, 2009
    Date of Event
    June 19, 2009
    Report Date
    June 19, 2009
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE PERFORMED A CONTROL TEST AND REC'D A RESULT OF 53 MG/DL. THE NORMAL CONTROL RANGE WAS 113-162 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE TO BE RETURNED FOR EVAL, BUT THE QA LAB DID NOT RECEIVE THEM. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 1440 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK