BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2034886 · Received March 1, 2011

    Report

    Report Number
    2027969-2011-00420
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 REFERENCE. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO2: 7.5, REFERENCE METER: 2.3. NURSE'S INRATIO2 METER. TARGET RANGE IS 2.0 - 3.0 INR. CONFIRMED PT IS ON JUST COUMADIN AND AVELOX, NO CHANGE IN DIET. TESTING ON PT METER USED LOT 243934 (JUST RECEIVED NEW STRIPS 3 WEEKS AGO). THE NURSE USED STRIP LOT 243396 ON HER INRATIO2. CONFIRMED NURSE USED 2 DIFFERENT FINGERSTICK FOR EACH TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1