BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2190124 · Received June 30, 2011

    Report

    Report Number
    2027969-2011-01445
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. PT'S THERAPEUTIC RANGE: 2.0-2.5 INR. PT GOT QC2H ERRORS FROM THE INRATIO METER ON (B)(6) 2011. COUMADIN WAS ADJUSTED DUE TO HIGH LAB RESULTS AND PT WAS ABLE TO GET BACK WITHIN THERAPEUTIC RANGE AND HAS STAYED THERE SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 241836

    Patients

    Seq Age Sex Outcome Treatment
    1 NI