BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 3213332 · Received July 2, 2013

    Report

    Report Number
    2027969-2013-00539
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 2, 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
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2013, INRATIO: 2.9; DATE: (B)(6) 2013, LAB: 6.6. THERAPEUTIC RANGE: 2-3. PT SELF TESTER WENT TO THE EMERGENCY ROOM TODAY DUE TO "BRUISING EVERYWHERE" AND CHEST PAIN; WAS TOLD TO STOP WARFARIN DOSE FOR THE NEXT TWO DAYS (NO VITAMIN K GIVEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301206 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 308628

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization