BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1812748 · Received August 16, 2010

    Report

    Report Number
    2027969-2010-01219
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 8, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PT SELF TESTED WITH ANTI-PHOSPHOLIPID ANTIBODY SYNDROME BEGAN USING INRATIO IN (B)(6) 2009. PT HAD AN INRATIO RESULT OF 2.3 ON (B)(6) 2010, THEN DID NOT USE INRATIO METER FOR SEVERAL MONTHS. PT'S TARGET THERAPEUTIC RANGE IS 3.0-3.5. PT WENT TO HOSPITAL ON (B)(6) 2010 NOT FEELING WELL. LAB RESULTS WERE INR=1.04. MULTIPLE CLOTS WERE FOUND IN PT'S LUNG. PT WAS HOSPITALIZED AND TREATED WITH COUMADIN AND LOVENOX. PT BEGAN USING INRATIO METER AGAIN. PT REPORTS DISCREPANT RESULTS: DATE: (B)(6) 2010, INRATIO: 4.4, LAB: 2.1; DATE: (B)(6) 2010, INRATIO: 5.8, LAB: 3.1; DATE: (B)(6) 2010, INRATIO: 5.0; DATE: (B)(6) 2010, INRATIO: 6.1; DATE: (B)(6) 2010, INRATIO: 3.4; DATE: (B)(6) 2010, INRATIO: 6.5; DATE: (B)(6) 2010, INRATIO: 3.7, MD METER: 2.7 (USING BLOOD FROM FINGERSTICK COLLECTED IN A GLASS TUBE BY RN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 175LN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other