BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1924779 · Received December 10, 2010

    Report

    Report Number
    2027969-2010-02149
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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: 3.2, LAB: 20.3 DATE: (B)(6) 2010, INRATIO: 3.5, LAB: 11, DIFFERENT POC METER: 11. SIX HOURS BETWEEN TESTS ON (B)(6) 2010. NO SIGN OF BLEEDING AND MINIMAL BRUISING. TRIED A CORRELATION WITH ANOTHER PT AND IT MATCHED PERFECTLY WITH THE LAB: INRATIO INR = 1.5, LAB INR = 1.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 235738

    Patients

    Seq Age Sex Outcome Treatment
    1