BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1853443 · Received September 28, 2010

    Report

    Report Number
    2027969-2010-01600
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANT RESULTS WITH METER COMPARED TO LAB. DATE: (B)(6) 2010, INRATIO: 1.3, LAB: 4.6. RESULTS DRAWN WITHIN 1 HOUR OF EACH OTHER. PATIENT'S TARGET THERAPEUTIC RANGE IS 2.0 - 3.0.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1