BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2040025 · Received March 9, 2011

    Report

    Report Number
    2027969-2011-00470
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" 1.0, 2.3, 2.2. CUSTOMER REPORTED PRECISION ISSUE ON 1 PT YESTERDAY. GOT INR OF 1.0; THEN RETESTED 2X AND GOT 2.3 AND 2.2. STUCK THE PT'S FINGER BEFORE GREEN LIGHT FOR 1ST TEST. THE NEXT TWO TESTS WERE MUCH QUICKER AND AFTER THE GREEN LIGHT WAS ON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1