BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2961148 · Received February 8, 2013

    Report

    Report Number
    2027969-2013-00121
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 8, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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) 2013, INRATIO: 4.9; LAB: 6.9. PT'S THERAPEUTIC RANGE IS 2.0-3.0. RESULTS WERE OBTAINED WITHIN 1 HOUR OF EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54748 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 294978

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN