BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1765669 · Received July 13, 2010

    Report

    Report Number
    2027969-2010-00941
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Date of Event
    June 9, 2010
    Report Date
    July 13, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K072727
    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: 1.41, LAB: 2.5. ADDITIONAL DATA: (B)(6)2010 METER 5.1, (B)(6)2010 LAB 2.0, (B)(6) METER 1.5. HAS BEEN ON COUMADIN APPROXIMATELY 10 YEARS. NOT ON HEPARIN, LOVENOX, AMIODARONE, ABX. NO CANCER, ANEMIA, APS, LUPUS, THYROID DYSFUNCTION. NO CHANGE IN RXS. NO CHANGE IN LIFESTYLE (DIET, EXERCISE, STRESS). LONG TIME PATIENT SELF TESTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 227900

    Patients

    Seq Age Sex Outcome Treatment
    1