BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2921898 · Received January 15, 2013

    Report

    Report Number
    2027969-2013-00050
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS IN COMPARISON TO THE LAB RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2013, INRATIO INR: 5.0, LAB INR: 1.6. THE TIME BETWEEN TESTING WAS IMMEDIATELY. THERAPEUTIC RANGE 2.0 - 3.0 FOR PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22582 INRATIO PROTHROMBIN TIME GJS ALERE SAN DIEGO, INC 100139 293081

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN