BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2 TEST STRIPS

    MDR report key: 863787 · Received June 7, 2007

    Report

    Report Number
    1826988-2007-00298
    Event Type
    Malfunction
    Date Received
    June 7, 2007
    Date of Event
    June 1, 2007
    Report Date
    June 1, 2007
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL. SHE PERFORMED CONTROL TESTS AND SAID THE RESULTS WERE OUT OF RANGE. SHE DID NOT PROVIDE ANY SPECIFIC VALUES. WHILE TROUBLESHOOTING, SHE PERFORMED A CONTROL TEST USING HIEGHT CONTROL SOLUTION. SHE RECEIVED A RESULT OF 347 MG/DL. THE HIGH CONTROL RANGE WAS 232-302 MG/DL. THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION, AND REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 TEST STRIPS BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 1466 1A5025AA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR