BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3082588 · Received April 24, 2013

    Report

    Report Number
    2027969-2013-00333
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ALERE 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: 1.1, LAB: 4.2. PATIENT'S THERAPEUTIC RANGE: 2.0-3.0. TIME: BETWEEN TESTING WAS IMMEDIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175681 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC. 100071 300671

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN