BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2772169 · Received October 2, 2012

    Report

    Report Number
    2027969-2012-01430
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 2, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    NI
    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

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2012, INRATIO2: 7.5, LAB: 3.3. TIME ELAPSED BETWEEN EACH METHOD OF TESTING IS THREE OURS. PT'S THERAPEUTIC RANGE IS 2.5-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 287168

    Patients

    Seq Age Sex Outcome Treatment
    1 NI