BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 1759151 · Received June 30, 2010

    Report

    Report Number
    2027969-2010-00874
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 30, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 1.2, LAB 2.8. PATIENT HAS AN INR OF 5.0 LAST WEEK. ADJUSTED COUMADIN DOSAGE PRIOR TO TESTING 1.2 THIS WEEK. LAB DRAW WAS DONE WITHIN 10 MINUTES. PATIENT WAS NOT ON HEPARIN/LOVANOX, NOT RECENTLY HOSPITALIZED, NO ANTIBIOTICS, NO CHANGES IN DIET, NO CANCER DIALYSIS. PATIENT AT 5.0 HAD NO BRUISING OR BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 229062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other