BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1813170 · Received August 18, 2010

    Report

    Report Number
    2027969-2010-01232
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PT'S WIFE REPORTED DISCREPANT RESULTS: APPROX 10 DAYS AGO: INRATIO: 1.5, LAB: 2.2. ON (B)(6) 2010: INRATIO: 1.7, LAV: 2.0. LAB RESULTS ABOUT 60-90 MINUTES AFTER METER RESULTS. PT HAS TO MILK HIS FINGERS TO GET A GOOD BLOOD SAMPLE. USUALLY DO FINGERSTICK BEFORE OR JUST AFTER INSERTING STRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 235793

    Patients

    Seq Age Sex Outcome Treatment
    1 Other