BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1760125 · Received July 9, 2010

    Report

    Report Number
    2027969-2010-00928
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    June 16, 2010
    Report Date
    July 9, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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: INRATIO: 1.8, COAGUCHECK: 2.1. PT TESTED USING HIS DOCTOR'S COAGUCHECK. THE PT WENT HOME AND 2-3 HOURS LATER TESTED ON HIS INRATIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 224380

    Patients

    Seq Age Sex Outcome Treatment
    1