BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3050536 · Received March 7, 2013

    Report

    Report Number
    2027969-2013-00196
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    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

    PT SELF TESTER ALLEGING DISCREPANT RESULTS. INRATIO 4.9, LAB 1.6. TIME BETWEEN TESTS 2 HOURS. PT'S THERAPEUTIC RANGE 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98462 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 297452

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN, STOPPED IN PREP FOR PROCEDURE