BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2 TEST STRIPS (50)

    MDR report key: 1032080 · Received April 18, 2008

    Report

    Report Number
    1826988-2008-00435
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HIS BREEZE2 METER. WHILE TROUBLESHOOTING, HE PERFORMED CONTROL TESTS AND RECEIVED RESULTS OF 166 AND 212 MG/DL. THE NORMAL CONTROL RANGE WAS 90-124 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE2 TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 1465 1T5143AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK