BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2221671 · Received August 15, 2011

    Report

    Report Number
    2027969-2011-01815
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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) 2011, INRATIO: 2.6, LAB: 1.9; (B)(6) 2011, 1.3, 1.9. THERAPEUTIC RANGE 2.0-3.0. WIFE OF PATIENT IS HEALTHY, NOT ON COUMADIN AND DID A TEST OVER THE PHONE WITH TECH SERVICE AND THE RESULT WAS 1.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 254609

    Patients

    Seq Age Sex Outcome Treatment
    1