BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1982599 · Received January 12, 2011

    Report

    Report Number
    2027969-2011-00080
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 8, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2010, INRATIO: 2.1. DATE: (B)(6) 2010, LAB: 2.5. PT SELF TESTER STOPPED COUMADIN PRIOR TO A HOSPITAL PROCEDURE ON (B)(6) 2010 AND A STARTED PLAVIX. TESTED ON INRATIO (B)(6) 2010 AND HAD A 2.1 INR. WHEN ASKED IF HE HAS HAD ANY BRUISING OR BLEEDING, PT STATES THAT HE STUBBED HIS TOE AND CUT HIS FINGER, BUT NEITHER HAD ANY PROLONGED BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 235737

    Patients

    Seq Age Sex Outcome Treatment
    1