BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3109518 · Received April 30, 2013

    Report

    Report Number
    2027969-2013-00349
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    DISCREPANT RESULTS ON ONE PATIENT. DATE: (B)(6) 2013, INRATIO = 3.6. DATE: (B)(6) 2013, LAB = 16.5. TWENTY FOUR HOURS BETWEEN TESTING. PATIENT HOSPITALIZED DUE TO BLEEDING OUT AND BRUISING. PATIENT RECEIVED VITAMIN K TO LOWER INR. PATIENT RECEIVED BLOOD TRANSFUSION FOR ANEMIA. PATIENT'S THERAPEUTIC RANGE 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186162 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 304245

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization IRON PILL| PATIENT JUST FINISHED ANTIFUNGAL MEDICATION ON| COUMADIN