BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2915459 · Received January 10, 2013

    Report

    Report Number
    2027969-2013-00022
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    October 22, 2012
    Report Date
    January 10, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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) 2012, INRATIO >7.5, LAB 3.2. PT'S THERAPEUTIC RANGE 2 - 3. PT DID NOT USE THE FIRST DROP OF BLOOD AND WAS MILKING FINGER AFTER FINGER STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14940 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 274166

    Patients

    Seq Age Sex Outcome Treatment
    1 METAPROLOL| WARFARIN| ALIVE MULTIVITAMIN WITH K| ASPIRIN