BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 963190 · Received December 10, 2007

    Report

    Report Number
    1826988-2007-00767
    Event Type
    Malfunction
    Date Received
    December 10, 2007
    Date of Event
    November 12, 2007
    Report Date
    November 12, 2007
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB FOUND THE RETURNED REAGENT TO READ AN AVERAGE OF 48MG/DL HIGH, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENSION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN FOR HELP WITH HIS CONTOUR METER. HIS INITIAL COMPLAINT DID NOT MEET THE CRITERIA FOR REPORTING, BUT HIS TEST STRIPS WERE RETURNED AND EVALUATED BY THE QA LAB. NO ADVERSE EVENTS WERE ALLEGED. 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 PROVIDED 7CC3D08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR