BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1082808 · Received July 24, 2008

    Report

    Report Number
    1826988-2008-00797
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 29, 2008
    Report Date
    June 29, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB PERFORMED 5 CONTROL TESTS USING THE RETURNED REAGENT. ONE OUT OF FIVE STRIPS READ 80 MG/DL LOW, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HIS CONTOUR METER. WHILE TROUBLESHOOTING, HE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF "LO". THE NORMAL CONTROL RANGE WAS 101-140 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE RETURNED FOR EVALUATION. 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 7080D 7FC3D16

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK