BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (10)

    MDR report key: 1031891 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00398
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 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

    Additional Manufacturer Narrative · 1

    THE REMAINING TEST STRIPS RECEIVED BY THE QA LAB WERE USED, SO IT WAS NOT POSSIBLE TO TEST. PERFORMANCE OF THE CUSTOMER'S METER WAS SATISFACTORY USING IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HIS METER. WHILE TROUBLESHOOTING, HE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 205 MG/DL. THE NORMAL CONTROL RANGE WAS 100-138 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS AND METER WERE RETURNED FOR EVALUATION. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (10) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 9507B 6JC3C52

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK