BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1765682 · Received July 13, 2010

    Report

    Report Number
    2027969-2010-00937
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Date of Event
    June 18, 2010
    Report Date
    July 13, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6)2010, INRATIO: 1.8, LAB: 3.02. NO HEPARIN, LOVENOX, AMIODARONE. ABX TAKEN AFTER BLOOD DRAW. NO CANCER, ANEMIA, APS, LUPUS. HAS BEEN ON COUMADIN SINCE (B)(6) 2009. NO CHANGE IN RXS / OTCS. NO ADVERSE TRENDS IN DIET AND EXERCISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 223043

    Patients

    Seq Age Sex Outcome Treatment
    1