BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3131491 · Received May 13, 2013

    Report

    Report Number
    2027969-2013-00383
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    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 INRATIO2 INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013; INRATIO INR: TEST #1 = 3.3, TEST #2 = 1.1, TEST #3 = 2.7. REPORTEDLY, THE PATIENT HAD DIFFICULTY AND HAD TO MILK THE FINGER WITH TESTS #1 AND #2, THE SAME PUNCTURE SITE WAS USED FOR TESTS #1 AND #2, THE METER WAS NOT IN THE CORRECT MODE WHEN FINGER STICK WAS PERFORMED AND THE FINGER WAS TOUCHED TO THE SAMPLE WELL. THE TIME BETWEEN TESTING WAS WITHIN MINUTES. THERAPEUTIC RANGE IS 2.0 - 3.0 FOR THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211888 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 305773

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED ORAL STERIOD| DIABETES MEDICATION| COUMADIN