BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1833431 · Received September 8, 2010

    Report

    Report Number
    2027969-2010-01383
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 19, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCREPANT METER RESULTS WHEN COMPARED WITH LAB RESULTS. DATE: (B)(6) 2010; INRATIO: 1.6; LAB: 3.0. DATE: (B)(6) 2010; INRATIO: 2.1, LAB: 3.3. PATIENT TARGET RANGE IS FROM 2.0 TO 3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 234586

    Patients

    Seq Age Sex Outcome Treatment
    1