BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2925003 · Received January 17, 2013

    Report

    Report Number
    2027969-2013-00060
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 17, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO2 METER COMPARED TO THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: (1.4), LABORATORY: (2.6), TIME BETWEEN TESTS: (30 MINS). PT'S THERAPEUTIC RANGE IS 2.5-3.5. PT WAS ADMITTED TO THE EMERGENCY ROOM AND GIVEN A SHOT OF LOVENOX. CUSTOMER'S OPERATIONAL TECHNIQUES: CUSTOMER MILKS THE FINGER-STICK IN THE ATTEMPT TO COLLECT SUFFICIENT SAMPLE FOR THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26651 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 293019

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization WARFARIN| COUMADIN