BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1791175 · Received August 2, 2010

    Report

    Report Number
    2027969-2010-01105
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    July 7, 2010
    Report Date
    August 2, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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: 2.9, LAB: 2.5. DATE: (B)(6) 2010, INRATIO: 3.2, LAB: 2.4. METER-TO-LAB COMPARISONS WERE DONE ON DIFFERENT DAYS. PT NOT ON ANY MEDICATIONS, NO HEPARIN/LOVENOX. HE EATS SPINACH MID-WEEK, BUT NOT ON THE DAYS LEADING UP TO TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1