BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1841548 · Received September 17, 2010

    Report

    Report Number
    2027969-2010-01491
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PT SELF TESTER REPORTS DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2010, INRATIO TEST1: 4.1, INRATIO TEST2: >7.5, INRATIO TEST3: 3.3. ALL THREE RESULTS OCCURRED WITHIN 10 MINS. PT'S THERAPEUTIC RANGE IS 2.5-3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 233708

    Patients

    Seq Age Sex Outcome Treatment
    1