BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 905533 · Received March 12, 2007

    Report

    Report Number
    1826988-2007-00129
    Event Type
    Malfunction
    Date Received
    March 12, 2007
    Date of Event
    March 1, 2007
    Report Date
    March 1, 2007
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB FOUND THE RETURNED TEST STRIPS TO READ AN AVERAGE OF 109 MG/DL HIGH, OUT OF SPEC. PEFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER'S INITIAL COMPLAINT OF HIGH BLOOD GLUCOSE RESULTS DID NOT INITIALLY MEET THE CRITERIA FOR REPORTABILITY. THE CUSTOMER RETURNED HIS TEST STRIPS TO THE QA LAB FOR EVAL, AND THEY CONFIRMED HIGH RESULTS. 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 NOT GIVEN 5JB3A04

    Patients

    Seq Age Sex Outcome Treatment
    1 YR