BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3060880 · Received April 10, 2013

    Report

    Report Number
    2027969-2013-00284
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ALER SAN DIEGO INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH LAB. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013; INRATIO: 4.2, 3.4, 3.9; LAB: 5.1. THERAPEUTIC RANGE: 1.8 - 3.0. TIME: ALL TESTS WERE TAKEN WITHIN TWO HOURS OF EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148213 INRATIO PROTHROMBIN TIME TEST GJS ALER SAN DIEGO INC. 10071 304226

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| NO CHANGES TO DAILY MEDICATIONS| ASPRIN 81MG DAILY| PROTONIX| TYLENOL AS NEEDED| PLAVIX