BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3862852 · Received February 19, 2014

    Report

    Report Number
    2027969-2014-00140
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 31, 2014
    Report Date
    January 31, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGING RECEIVING DISCREPANT HIGH INRATIO VALUE. DATE: (B)(6) 2014, INRATIO 3.0, LAB: 2.02. TESTS PERFORMED WITHIN THE HOUR. PATIENT'S THERAPEUTIC RANGE 2.5 - 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105035 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 329654

    Patients

    Seq Age Sex Outcome Treatment
    1 B-12| HUMIRA| COUMADIN| BLOOD PRESSURE PILLS