BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2190084 · Received June 29, 2011

    Report

    Report Number
    2027969-2011-01430
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. CALLER ALSO ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 2.5, 2.0. PT'S THERAPEUTIC RANGE: 2.0-3.0 INR. PT HAS BEEN TESTING ON THE INRATIO1 METER FOR ABOUT 2 YEARS, UNTIL (B)(6) 2011, AT WHICH POINT KAISER SENT HER A NEW INRATIO2 METER. TESTS WERE DONE WITH 2 DIFFERENT STRIP LOTS. PT WAS UNABLE TO PROVIDE LOT NUMBERS FOR TESTS DONE BEFORE USING NEW STRIP LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1 NI