BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2903734 · Received January 4, 2013

    Report

    Report Number
    2027969-2013-00007
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 4, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS COMPARED TO THE LABORATORY RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO INR: 2.3, LABORATORY INR: 1.69. THE TIME BETWEEN TESTING WAS 10 MINUTES. THERAPEUTIC RANGE 2.0 - 3.0 FOR PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5244 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 291547

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN