BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 3830188 · Received March 12, 2014

    Report

    Report Number
    2027969-2014-00217
    Event Type
    Injury
    Date Received
    March 12, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 14, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS. CANNOT CONFIRM ORIGIN OF RESULTS (LAB, POC, INRATIO). RESULTS FROM INRATIO METER MEMORY. THERAPEUTIC RANGE: 2-3. (B)(6) 2014: COUMADIN HELD; RESUMED ON (B)(6) AT 1MG/DAT. (B)(6) 2014: COUMADIN HELD; BEGAN TAKING 1MG EVERY OTHER DAY ON (B)(6). DOSE CHANGE BASED ON INR RESULT FROM (B)(6) 2014. PT SELF TESTER WENT TO THE EMERGENCY ROOM ON (B)(6) 2014 WITH STOMACH PAINS, BLOOD IN URINE AND NOT FEELING WELL. A CAT SCAN WAS PERFORMED WITH CLEAR RESULTS. HE RECEIVED VITAMIN K TREATMENT AND HIS COUMADIN DOES WAS ALTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147722 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 315108

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other COUMADIN (1MG EVERY OTHER DAY)| ADDERALL (A COUPLE TIMES A MONT)