BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3082579 · Received April 24, 2013

    Report

    Report Number
    2027969-2013-00336
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ALERE SAN DIEGO INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6), INRATIO: 5.8, RE-TEST: 3.0 (5 MINUTES BETWEEN TESTS). DATE: (B)(6), INRATIO: 2.5, MD POC: 2.0 (SECONDS BETWEEN TESTS). THE SAME FINGER STICK SITE WAS USED FOR BOTH TESTS. THERAPEUTIC RANGE: 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175680 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC. 100071 301621

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN 1.5 MG