BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1864601 · Received October 5, 2010

    Report

    Report Number
    2027969-2010-01653
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANT RESULTS WITH METER COMPARED TO LAB. CUSTOMER HAS BEEN USING INRATIO2 METERS FOR APPROX 1 YEAR. CUSTOMER TWO DIFFERENT METERS: (B)(4), WHICH HAS HAD MORE USE, AND (B)(4), WHICH THEY TOOK OUT OF USE TWO WEEKS AGO DUE TO PRIOR UNSPECIFIED DISCREPANCIES. METER (B)(4) RESULTS: DATE: (B)(6) 2010; PT: #1; INRATIO2: 4.1; RETEST INRATIO2: 5.7; LAB: 6.1. DATE: (B)(6) 2010: PT: #2: INRATIO2: 4.4: LAB: 3.1. LAB DRAW PERFORMED IMMEDIATELY AFTER INRATIO2 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 235738

    Patients

    Seq Age Sex Outcome Treatment
    1