BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2103738 · Received May 17, 2011

    Report

    Report Number
    2027969-2011-01099
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: >7.5, 5.5, LAB: 5.4, 5.4. CALLER ALSO REPORTED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: >7.5, 5.5. PT'S THERAPEUTIC RANGE: 2.0 - 2.5 INR. ON (B)(6) 2011, AFTER LAB READING CONFIRMED HIGH INR, PT WAS GIVEN VITAMIN K AND HER COUMADIN WAS HELD. SHE ALSO SHOWED SIGNS OF BRUISING AND HAD A HEADACHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243103

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other