BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 3962595 · Received July 14, 2014

    Report

    Report Number
    2027969-2014-00659
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT HIGH INR RATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014; INRATIO INR: 7.1; LABORATORY INR: 1.8: THERAPEUTIC RANGE: 2.0 - 3.0. THE TIME BETWEEN TESTING WAS SIXTY-FIVE (65) MINUTES. THE PATIENT WAS INSTRUCTED TO WITHHOLD WARFARIN THEN START 2MG 5X WEEKLY AND 1MG W/SAT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409380 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 341996

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other CELEBREX 200MG| FINASTERIDE 5MG,| VYTOREN 5/500 1/2 TAB 4X DAILY,| AMLODIPINE 5MG,| TORSEMIDE 5MG,| BENAZEPRIL 20MG 1/2 TAB,| COUMADIN 2MG X 4 DAYS AND 1 MG M/W/F,| INRATIO MONITOR: SN (B)(4),