BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1053388 · Received May 22, 2008

    Report

    Report Number
    1826988-2008-00534
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT THE CUSTOMER HAD BEEN RECEIVING HIGH BLOOD GLUCOSE READINGS. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED 2 RESULTS OF "HI". THE NORMAL CONTROL RANGE WAS 103-143 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 CONTOUR TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7097B 7DC3C04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK