BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3113136 · Received May 9, 2013

    Report

    Report Number
    2027969-2013-00379
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 PRECISION RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2013. INRATIO: 2.3, RE-TEST: >6.0. TIME BETWEEN TESTS: UNK. THERAPEUTIC RANGE: 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202703 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 304235

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN