BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2629395 · Received June 19, 2012

    Report

    Report Number
    2027969-2012-00944
    Event Type
    Injury
    Date Received
    June 19, 2012
    Date of Event
    May 19, 2012
    Report Date
    June 19, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: 3.5, HOSPITAL: 16. PT SELF TESTER WENT TO THE HOSPITAL RIGHT AFTER THE INRATIO METER TEST. PT WAS ADMITTED INTO THE HOSPITAL AND GIVEN VITAMIN K TO BRING HIS INR BACK DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 274163

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization