BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3843058 · Received March 14, 2014

    Report

    Report Number
    2027969-2014-00233
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 26, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGING RECEIVING DISCREPANT LOW INRATIO VALUE. ON (B)(6) 2014, INRATIO 2.5, LAB: 7.0. TIME BETWEEN TESTING 3 HOURS. PT'S THERAPEUTIC RANGE 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153710 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 332831

    Patients

    Seq Age Sex Outcome Treatment
    1 OPAIN MEDICATION ASPIRIN| ORAL ANTICOAGULANTS COUMADIN