BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3042103 · Received April 9, 2013

    Report

    Report Number
    1826988-2013-00146
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 16, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    JJX
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A LOW OUT OF RANGE CONTROL RESULT OF 75MG/DL ON HER CONTOUR METER. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER¿S MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE ISSUE WAS RESOLVED DURING THE CALL. NEW STRIPS WERE SENT. NO PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147241 CONTOUR QUALITY CONTROL MATERIAL JJX BAYER HEALTHCARE LLC 7109B 2392

    Patients

    Seq Age Sex Outcome Treatment
    1