BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1948416 · Received December 30, 2010

    Report

    Report Number
    2027969-2010-02310
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 30, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER. PT'S TARGET THERAPEUTIC RANGE IS 2.5-3.5. ON (B)(6) 2010, PT HAD BLOODSHOT EYES AND SKIPPED 2 DAYS OF COUMADIN DOSING DUE TO INR=5.9 RESULT. PT HAS BEEN EATING LESS OF FOODS WITH VITAMIN K TO TRY GET INR RESULT IN RANGE. PHYSICIAN DOSED PT ACCORDING TO LAB RESULT ON (B)(6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1