BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2081342 · Received April 28, 2011

    Report

    Report Number
    2027969-2011-00948
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, 1ST INRATIO INR: 1.4. DATE: (B)(6) 2011, 4.6, 2ND INRATIO INR: 4.3. COUMADIN LEVEL WAS INCREASED SLIGHTLY. THREE HOURS LATER, THE DOCTOR'S OFFICE SENT THE PT TO THE HOSPITAL TO HAVE A LAB TEST STAT BECAUSE THE PT REPORTED NOT FEELING WELL. PT'S THERAPEUTIC RANGE IS: (2.0-3.0).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other