BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2781922 · Received October 5, 2012

    Report

    Report Number
    2027969-2012-01454
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 AND THE DOCTOR'S METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO2: 6.2, 3.2, LAB: 8.1, DOCTOR'S METER: 8.0. CALLER ALSO REPORTED IMPRECISION WITH INRATIO2 METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: 6.2, 3.2. TIME BETWEEN TESTING OF EACH METHOD: 30 MINUTES. PATIENT'S THERAPEUTIC RANGE: 2.0-3.0 INR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI