BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2844408 · Received November 5, 2012

    Report

    Report Number
    2027969-2012-01593
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 METER. RESULTS AS FOLLOWS:" DATE: (B)(6) 2012, INRATIO2: 2.9, REFERENCE METER: 1.7. PROTIME3 TESTED IMMEDIATELY AFTER THE INRATIO FROM THE SAME FINGERSTICK SITE, THERAPEUTIC RANGE: 2.0-2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 291553

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN