BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1874505 · Received October 15, 2010

    Report

    Report Number
    2027969-2010-01747
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANT RESULTS WITH INRATIO METER COMPARED TO LAB AND A COAGUCHECK METER. DATE: (B)(6) 2010, INRATIO: 1.4, COAGUCHECK: 2.8, LAB: 2.8. DATE: (B)(6) 2010, INRATIO: 1.6, COAGUCHECK: 3.3, LAB: 2.8. PT'S THERAPEUTIC RANGE IS 2.5-4.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HS0100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1