BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 2810071 · Received October 24, 2012

    Report

    Report Number
    2027969-2012-01553
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 24, 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
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    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. ALERE HOME MONITORING (AHM) REPRESENTATIVE REPORTED A DISCREPANCY. RESULTS AS FOLLOW: DATE: (B)(6) 2012, INRATIO: 2.5, LAB > 13. CUSTOMER HAD GI BLEEDING. CUSTOMER WAS ADMITTED TO HOSPITAL. TECHNICAL SUPPORT CALLED THE CUSTOMER IN REGARDS TO DISCREPANCY. THE CUSTOMER WAS NOT AWARE OF ANY PROBLEMS WITH INR OR A CALL TO THE DISTRIBUTOR IN REGARDS TO PROBLEMS WITH INRATIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization