BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2082612 · Received April 27, 2011

    Report

    Report Number
    2027969-2011-00937
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 2.8; DATE: (B)(6) 2011, INRATIO: 1.6. PT REPORTS THAT THE DR CHANGED HIS COUMADIN DOSAGE A COUPLE WEEKS BACK DUE TO THE METER RESULTS, BUT HE HAS BEEN WITHIN HIS THERAPEUTIC RANGE UNTIL TODAY. PT HAS BEEN TAKING COUMADIN FOR ABOUT 3 YEARS, BUT STARTED USING THE INRATIO METER ON (B)(6) 2011. HE ALSO REPORTS THAT HE HAS A HARD TIME GETTING ENOUGH SAMPLE INTO THE MICRO SAFE TUBE. PT IS TAKING COUMADIN DUE TO HAVING AN ENZYME THAT IS CAUSING HIS BLOOD TO CLOT WHEN IT SHOULDN'T.

    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