BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1031876 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00369
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB PERFORMED 5 CONTROL TESTS USING THE RETURNED REAGENT. THEY FOUND 2 OUT OF 5 RESULTS TO READ 2 MG/DL HIGH, OUT OF SPECS. PERFORMANCE WAS SATISFACTORY USING THE IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HIS METER. WHILE TROUBLESHOOTING, HE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 221 MG/DL. THE NORMAL CONTROL RANGE WAS 103-143 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE RETURNED FOR EVAL. REPLACEMENT 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 7098B 7KC3D08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK