BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1031914 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00434
    Event Type
    Malfunction
    Date Received
    April 15, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE PERFORMED A CONTROL TEST AND RECEIVED A RESULT THAT WAS HIGH, OUT OF SPEC. HE PERFORMED CONTROL TESTS WHILE TROUBLESHOOTING AND RECEIVED RESULTS OF 178 AND 189 MG/DL. THE NORMAL CONTROL RANGE WAS 94-130 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 6MC3B06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK