BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3770219 · Received March 10, 2014

    Report

    Report Number
    2027969-2014-00204
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 20, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGING RECEIVING DISCREPANT INRATIO VALUES. ON (B)(6) 2014 INRATIO=1.0, LAB= 3.5 TIME BETWEEN TESTING 1-1/2 HOURS. TWO HOURS LATER, ON (B)(6) 2014 INRATIO=2.1, POC=3.5 MINUTES APART, PATIENT'S THERAPEUTIC RANGE 1.8 - 2.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143615 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 332831

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN AND ASPIRIN