BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1812745 · Received August 16, 2010

    Report

    Report Number
    2027969-2010-01211
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    DISCREPANT RESULTS ARE ALLEGED TO HAVE OCCURRED FOR SEVERAL PTS. THESE INDIVIDUALS ARE NOT UNDERGOING COUMADIN THERAPY, AND REPORTER CLAIMED THEIR RESULTS WERE AT OR AROUND INR=6.0. TECHNICAL CONSULTANT PERFORMED SEVERAL SELF TESTS AND OBTAINED SIMILAR RESULTS. ACCOUNT EXECUTIVE PERFORMED SELF TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 234589

    Patients

    Seq Age Sex Outcome Treatment
    1 Other