BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 2081315 · Received April 27, 2011

    Report

    Report Number
    2027969-2011-00943
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 27, 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
    TX, 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: 3.3, LAB: 50.0. PT HAD BRUISING AND WAS IMMEDIATELY ADMITTED TO THE HOSPITAL. CALLER STATED THAT RESULT OF 50.0 INR WAS CONFIRMED BY THE LAB AND THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 240450

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization| O