BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 1493942 · Received August 18, 2009

    Report

    Report Number
    1826988-2009-00710
    Event Type
    Malfunction
    Date Received
    August 18, 2009
    Date of Event
    July 29, 2009
    Report Date
    July 29, 2009
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT HE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 350 MG/DL USING HIS BREEZE2 METER. THE NORMAL CONTROL RANGE WAS 113-163 MG/DL. THE CUSTOMER DID NOT HAVE THE CONTROL SOLUTION WITH HIM AT THE TIME OF THE CALL, SO FURTHER TROUBLESHOOTING WAS NOT POSSIBLE. NO ADVERSE EVENTS WERE ALLEGED. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    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