BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3810858 · Received March 20, 2014

    Report

    Report Number
    2027969-2014-00257
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: (B)(6) 2014: INRATIO = 3.8; 2ND INRATIO TEST: 2.2. APPROXIMATELY 10 MINUTES BETWEEN RESULTS. PATIENT'S TARGET THERAPEUTIC RANGE: 2.0 -3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166637 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 329655

    Patients

    Seq Age Sex Outcome Treatment
    1