BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1973092 · Received January 19, 2011

    Report

    Report Number
    2027969-2011-00138
    Event Type
    Other
    Date Received
    January 19, 2011
    Date of Event
    November 22, 2010
    Report Date
    January 19, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010, INRATIO: 1.7, LAB: 4.8. CUSTOMER MEDICATION WAS INCREASED DUE TO LOW RESULT ON INRATIO PRIOR TO COMPARING ON INRATIO AT DOCTOR'S OFFICE. ON (B)(6) 2010, CUSTOMER GOT 1.7 ON HOME INRATIO AND 2 HOURS LATER GOT 4.8 ON INRATIO AT DOCTOR'S OFFICE. THERAPEUTIC RANGE 2.0-3.0. PT RECEIVED NEW METER (B)(4) AND IS STILL HAVING CORRELATION ISSUES: (B)(6) 2011 - LAB DRAW INR = 3.4; (B)(6) 2011 - TESTED ON METER 2X WITHIN 6 MINUTES OF EACH OTHER (AFTER BATTERIES WERE CHANGED) AND USED DIFFERENT FINGER INR = 1.2, 1.3 THEN WENT TO GET A LAB DRAW WITHIN THE HOUR INR = 2.7. OLD STRIP LOT (#235737) WAS USED BECAUSE NEW METER WAS RECEIVED FIRST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 235737

    Patients

    Seq Age Sex Outcome Treatment
    1 Other