BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    MDR report key: 3023794 · Received March 25, 2013

    Report

    Report Number
    2027969-2013-00246
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 25, 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
    FL, US
    Reporter Occupation
    OTHER

    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)2013, INRATIO: 1.8; (B)(6) 2013, LAB: 3.2. TIME BETWEEN TESTING WAS REPORTED AS 2 DAYS. PT'S THERAPEUTIC RANGE IS 1.5 - 2.5. IT WAS REPORTED THE PT WENT TO THE HOSPITAL FOR KIDNEY STONES AND THIN BLOOD. IT WAS REPORTED THE PT WAS TAKEN OFF WARFARIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121340 INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ALLOPURINOL (100MG)| GLUCOSAMINE/CHONDROITIN| NORVASC (10MG)| IT WAS ALSO REPORTED THE PST MAY HAVE BEEN ON| LIPITOR (40MG)| LISINOPRIL (40MG)| ZETIA (10MG)| DOXYCYCLINE AT THE TIME.| ASPIRIN (81MG)| WARFARIN (6MG)