BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2862163 · Received November 29, 2012

    Report

    Report Number
    2027969-2012-01647
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 5, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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) 2012, INRATIO: 3.8, LAB: 5.7; 11/08/2012, 4.4, 5.8. THERAPEUTIC RANGE = 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 291809

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN - 4MG DAILY (ON DOSAGE DURING BOTH TESTS)| LOVENOX = STOPPED TAKING LOVENOX 1 WEEK PRIOR| TO TEST #1 (10/5)| VICODIN - DOSAGE NOT GIVEN, CURRENTLY TAKING