BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 3962694 · Received June 19, 2014

    Report

    Report Number
    2027969-2014-00593
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K0982987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT HIGH INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014. INRATIO INR: 7.5, 2.4 AND 3.1. LABORATORY INR: 2.1. THERAPEUTIC RANGE: 2.0 - 3.0. THE INRATIO TESTS WERE PERFORMED IMMEDIATELY AFTER ONE ANOTHER. THE LABORATORY TEST WAS PERFORMED WITHIN 5 MINS OF THE INRATIO TESTS. REPORTEDLY, MULTIPLE FINGER STICKS WERE PERFORMED ON THE SAME FINGER. 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
    359160 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 343287

    Patients

    Seq Age Sex Outcome Treatment
    1 ASPIRIN| COUMADIN| INRATIO MONITOR, SN (B)(4)