BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 1919753 · Received December 3, 2010

    Report

    Report Number
    2027969-2010-02110
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 3, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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) 2010, INRATIO: 1.6, LAB: 3.2. DISCREPANT LOW FOR PT AFTER SURGERY (1.4-1.6 METER AND 3.2 LAB); PT HAD 1 DAY OF ANTIBIOTICS. HE HAD SURGERY RECENTLY TO REPLACE HIS PACEMAKER AND HAS HAD UNEXPECTED LOW RESULTS ON HIS METER SINCE THEN. ON (B)(6) - HAD SURGERY. HE WAS OFF HIS COUMADIN FOR 3 DAYS BEFORE AND ON LOVENOX FOR THE 2 DAYS BEFORE. NO COUMADIN OR LOVENOX ON DAY OF SURGERY. GIVEN INTRAVENOUS ANTIBIOTICS IN THE HOSPITAL. STARTED COUMADIN THE NIGHT AFTER SURGERY. ON (B)(6) - HAD 1.4 ON METER. DOCTOR RAISED COUMADIN DOSE. MID-WEEK (DATE UNK) - HAD 1.5 ON METER. ON (B)(6) - PT HAD LEAKAGE FROM INCISION. WENT TO DOCTOR'S AND HAD LAB TEST DONE TO CHECK INR. LAB WAS 3.2. TEST ON METER ABOUT 1-2 HR LATER WAS 1.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other