BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 2141065 · Received June 15, 2011

    Report

    Report Number
    2027969-2011-01351
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011; INRATIO: >7.5; RE-TEST: 3.7; RE-TEST: >7.5; LAB: 12.2. TESTS DONE WITHIN AN HOUR. THE SAME FINGER WAS USED FOR THE FIRST AND SECOND TEST, A DIFFERENT FINGER WAS USED FOR THE FOR THE THIRD TEST. PT'S COUMADIN DOSE WAS HELD DUE TO LAB RESULT. NO BRUISING/BLEEDING REPORTED. PREVIOUS RESULTS: DATE: (B)(6) 2011; INRATIO: 3.5. DATE: (B)(6) 2011; INRATIO: 2.7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 251112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other