BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3884157 · Received May 19, 2014

    Report

    Report Number
    2027969-2014-00458
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO LOW INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014; INRATIO INR: 1.6; LABORATORY INR: 2.8. THE TIME BETWEEN TESTING WAS ONE (1) HOUR. REPORTEDLY, MULTIPLE DROPS OF BLOOD WAS ADDED TO THE STRIP. THERAPEUTIC RANGE 2.3 - 2.6 FOR THE PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296987 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 334474

    Patients

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