BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1786449 · Received July 27, 2010

    Report

    Report Number
    1826988-2010-00497
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 10, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    QA EVALUATED THE RETURNED REAGENT AND FOUND IT TO READ AN AVERAGE OF 405 MG/DL HIGH, OUT OF SPEC. SATISFACTORY PERFORMANCE USING IQA REAGENT.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A CONTROL READING OF 493 MG/DL WHICH IS HIGH OUT OF SPEC. THE NORMAL CONTROL RANGE IS 106-146 MG/DL. REPLACEMENT STRIPS WERE SENT TO THE CUSTOMER. CUSTOMER'S STRIPS HAVE BEEN EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE LLC 7098C 9HC3C03A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK