BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1873964 · Received October 14, 2010

    Report

    Report Number
    2027969-2010-01736
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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) 2010; INRATIO: 2.5, 2.5; LAB METER: 4.0, 4.3. TESTING DONE WITHIN 5 MINUTES OF ONE ANOTHER ON DIFFERENT FINGERS. PATIENT THERAPEUTIC RANGE IS 3.0-4.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1