BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2197829 · Received August 1, 2011

    Report

    Report Number
    2027969-2011-01704
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    July 5, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K LISTED IS FOR THE INRATIO2 METER. TESTING WAS ALSO PERFORMED USING AN INRATIO METER. THE 510K FOR THE INRATIO METER IS K021923. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE REFERENCE. RESULTS AS FOLLOWS:" DATE: (B)(6) 2011, INRATIO: 1.8, INRATIO2: 5.1. COMPARED WITH INRATIO METER BECAUSE PT INR RESULT WAS BELOW 2.0 LAST WEEK ON INRATIO2 METER. NO SPECIFIC DATA AVAILABLE. THERAPEUTIC RANGE 2.0-3.0. TESTED BOTH METERS USING THE SAME LOT ON NON-COUMADIN PT. RESULTS WERE WITHIN NORMAL RANGE. INRATIO2 INR=1.0, INRATIO INR=1.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 246364

    Patients

    Seq Age Sex Outcome Treatment
    1