BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1803479 · Received August 9, 2010

    Report

    Report Number
    2027969-2010-01158
    Event Type
    Other
    Date Received
    August 9, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: 4.4; LAB: 4.0. DATE: (B)(6) 2010, INRATIO: 2.7. DATE: (B)(6) 2010; INRATIO: 2.7. DATE: (B)(6) 2010; INRATIO: 1.2. DATE: (B)(6) 2010, INRATIO: 5.5, LAB: 10.0. COUMADIN WAS 4 MG ON (B)(6) AND REDUCED TO 3 MG ON (B)(6). NO COUMADIN CHANGE AFTER (B)(6). NO OTHER MEDICATION CHANGE. PT HAS NO BLEEDING SYMPTOMS ON (B)(6), BUT HAD ABDOMINAL PAIN. PT WAS NOT HOSPITALIZED, BUT TREATED WITH VIT K. PT NOT ON HEPARIN/LMWH. NOT ANEMIC, ON CHEMO OR DIALYSIS. NO THYROID, LIVER, OR AUTOIMMUNE DISEASE. HE HAD CHRONIC KIDNEY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 232889

    Patients

    Seq Age Sex Outcome Treatment
    1 Other