BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1874482 · Received October 15, 2010

    Report

    Report Number
    2027969-2010-01742
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT PRECISION RESULTS USING THE INRATIO METER. RESULTS AS FOLLOWS: DATE: LAST WEEK, INRATIO: 2.1; (B)(6) 2010, INRATIO: 1.3, RE-TEST: 1.7; (B)(6) 2010, INRATIO: 1.5. DOCTOR RAISED THE PATIENT'S COUMADIN DOSE FROM 5 TO 8 MG/DAY ON (B)(6) 2010. PATIENT IS BEING TESTED BY A HOME HEALTH NURSE. PATIENT IS HAVING A PROCEDURE DONE THAT REQUIRES HER INR TO BE ABOVE 2.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 222168

    Patients

    Seq Age Sex Outcome Treatment
    1 Other