BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2000495 · Received January 31, 2011

    Report

    Report Number
    1826988-2011-00035
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 6, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) CONTACTED CUSTOMER SERVICE ABOUT HIS DAUGHTER'S CONTOUR LINK METERS. HE ALLEGED THAT HER GLUCOSE WAS TESTED USING BOTH METERS AND SHE RECEIVED READINGS OF 583 AND 140 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER'S TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT TEST STRIPS AND NEW METERS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC NOT PROVIDED 9JC3A04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK