BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2150366 · Received June 8, 2011

    Report

    Report Number
    2027969-2011-01278
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO2 METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 9.0. DATE: (B)(6) 2011, INRATIO2: 1.6, LAB: 3.1 (VENOUS SAMPLE). LAB WAS DONE WITHIN AN HOUR OF THE INRATIO METER TEST. PATIENT TARGET RANGE ON THE METER IS 2.0-3.0 INR. PATIENT IS ON COUMADIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 NOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 NI