BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1780884 · Received July 27, 2010

    Report

    Report Number
    2027969-2010-01067
    Event Type
    Other
    Date Received
    July 27, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 27, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: 1.7, LAB: 8.9. THE TIME DIFFERENCE BETWEEN TESTING WITH INRATIO AND LAB WAS APPROXIMATELY 12 HOURS. FRIDAY (B)(6): PATIENT WAS FEELING ILL AND WAS PRESCRIBED LEVOFLOXACIN. PREVIOUS INR ON (B)(6) WAS 1.8. THE PATIENT STARTED LEVOFLOXACIN 500MG DAILY ON FRIDAY. BECAUSE OF LIKELY INTERACTION BETWEEN WARFARIN AND LEVOFLOXACIN, HIS WARFARIN DOSE FOR THE WEEKEND WAS CUT FROM 5MG F-SU TO 2.5, 2.5, 5MG. MONDAY (B)(6): PATIENT INR READING 1.7. COAGCARE ATTEMPTED TO INCREASE DAILY DOSE AND WEEKLY DOSE. HOWEVER, DOSE WAS KEPT AT 5MG DAILY DUE TO LIKELY INTERACTION WITH LEVOFLOXACIN. PATIENT REPORTED NO SYMPTOMS OF BLEEDING. HE DID REPORT A FEVER AND INCREASED SHORTNESS OF BREATH. PATIENT CONTACTED HIS DOCTOR LATER THAT NIGHT WITH INCREASED BREATHLESSNESS AND PRODUCTIVE COUGH (BROWN TINGED). MD SENT PATIENT TO ER AND PATIENT WAS LATER ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 225433

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O