BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2121287 · Received May 5, 2011

    Report

    Report Number
    2027969-2011-00996
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS USING THE INRATIO2 METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011; INRATIO: 3.0. DATE: (B)(6) 2011; INRATIO: 1.6. PT'S DOCTOR ADJUSTED COUMADIN DOSE. NO LAB CONFIRMATION DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 240450

    Patients

    Seq Age Sex Outcome Treatment
    1