BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1945903 · Received December 28, 2010

    Report

    Report Number
    2027969-2010-02287
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 28, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: PT 1, DATE: (B)(6) 2010, INRATIO2: 1.8, LAB: 2.1. PT 2, DATE: (B)(6) 2010, INRATIO2: 4.X, LAB: 3.2. DECIMAL VALUE FOR PT 2 METER RESULT IS UNK. RESULTS WERE DONE MORE THAN AN HOUR APART.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1