BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2924979 · Received January 17, 2013

    Report

    Report Number
    2027969-2013-00064
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH THE INRATIO2 METER COMPARED TO THE LAB. RESULTS AS FOLLOW: DATE: (B)(6) 2013, INRATIO: 2.4, LAB: 4.7, TIME BETWEEN TESTING: (TWO HRS). PT'S THERAPEUTIC RANGE IS 2.0-3.0. PT WAS HOSPITALIZED DUE TO VAGINAL BLEEDING PRIOR TO TESTING ON THE INRATIO METER. LAB RESULT WAS OBTAINED BEFORE PT WENT HOME AND TESTED ON THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25956 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 274164

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization INSULIN| COUMADIN