BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3111836 · Received May 7, 2013

    Report

    Report Number
    2027969-2013-00375
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGING DISCREPANT INRATIO VALUES. INRATIO 1.2, DR. POC 2.1. INRATIO 1.8, DR. POC 2.0. TIME BETWEEN TESTING ONE HR. PT'S THERAPEUTIC RANGE 2.0 - 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199879 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 305773

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN