BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1853706 · Received September 29, 2010

    Report

    Report Number
    2027969-2010-01605
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: 5.5; LAB: 1.3. APPROX 10 MINS DIFFERENCE BETWEEN FINGER STICK AND VENOUS DRAW. PT UNDERGOING HEPARIN BRIDGING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 235738

    Patients

    Seq Age Sex Outcome Treatment
    1