BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3082620 · Received April 23, 2013

    Report

    Report Number
    2027969-2013-00328
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 1.3; LAB: 3.6. THERAPEUTIC RANGE: UNKNOWN. TIME: 1 HOUR BETWEEN TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173513 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 305773

    Patients

    Seq Age Sex Outcome Treatment
    1 TRAMADOL| COUMADIN