BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1031898 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00417
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB EVALUATED THE RETURNED REAGENT AND FOUND IT TO READ E11 (CONFIRMS EXPOSURE) AND AN AVERAGE OF 8 MG/DL HIGH, OUT OF SPEC. THEY WERE NOT ABLE TO CONFIRM LOW RESULTS.

    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 "LO." THE NORMAL CONTROL RANGE WAS 100-138 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE 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 7080D 7GC3C11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK