BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2801089 · Received October 17, 2012

    Report

    Report Number
    2027969-2012-01525
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER IS ONE OF MANY NURSES TESTING THE PT. THIS IS A NEW PT, FACILITY STARTED SEEING PT ON (B)(6). PT RECENTLY HOSPITALIZED FOR PNEUMONIA ON (B)(6), WHILE HOSPITALIZED DEVELOPED PULMONARY EMBOLISM. PT IS NEW TO TAKING COUMADIN. DOCTORS STARTED PT ON DAILY DOSES OF 5MG COUMADIN AND 40MG OF LOVENOX. PT HAS CEREBRAL PALSY, AND ON (B)(6) HAD DIFFICULTY GETTING FINGERSTICK. BROUGHT METER TO THE FINGER AND OBTAINED 6.7, THEN PERFORMED VENOUS DRAW, USED VENOUS SAMPLE ON INRATIO SYSTEM AND OBTAINED INR OF 6.0. VENOUS SAMPLE SENT TO LAB, LAB INR=>10. ON (B)(6) 2012, INRATIO: 6.7 AND 6.1, LAB: 10.0. TIME BETWEEN TESTING MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 282861

    Patients

    Seq Age Sex Outcome Treatment
    1