BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 3963306 · Received May 29, 2014

    Report

    Report Number
    2027969-2014-00508
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO HIGH INR RESULT IN COMPARISON TO THE LAB INR RESULT. RESULTS ARE AS FOLLOWS: DATE - (B)(6) 2014; INRATIO INR: 6.0; LAB INR: 1.5. THE TIME BETWEEN TESTING WAS TWO (2) HRS. REPORTEDLY, THE PT "MILKING" THE FINGER AFTER THE FINGER STICK, AND UNABLE TO OBTAIN SUFFICIENT BLOOD SAMPLE. PT STATES THAT SHE STARTED SEEING HIGHER READINGS AFTER THE MONITOR WAS DROPPED ON (B)(6) 2014. THERAPEUTIC RANGE 2.0-3.0 FOR THE PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315594 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 333862

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR SN: (B)(4)