BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2772168 · Received October 2, 2012

    Report

    Report Number
    2027969-2012-01431
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 2, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH THE INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: (1.2, 1.4, AND 1.7). PT'S THERAPEUTIC RANGE: 2.0-3.0. CUSTOMER'S OPERATIONAL TECHNIQUE: CUSTOMER MILKS THE FINGER IN THE ATTEMPT TO COLLECT SUFFICIENT SAMPLE FOR THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 285228

    Patients

    Seq Age Sex Outcome Treatment
    1