BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3042306 · Received April 3, 2013

    Report

    Report Number
    2027969-2013-00276
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH THE INRATIO METER. COMPLAINT SUMMARY: DATE: (B)(6) 2013. THE FIRST INRATIO TEST: INR=4.1. THE SECOND INRATIO TEST: INR=1.1 (PERFORMED 5 HOURS AFTER THE FIRST TEST). THE THIRD INRATIO TEST: INR=1.8 (PERFORMED 10 MINUTES AFTER THE SECOND TEST). PT'S THERAPEUTIC RANGE IS 2 - 3. PT TESTED ON THREE DIFFERENT FINGERS, USING DIRECT DROP FROM FINGER. PT APPLIED FIRST DROP AND NO ADD'L DROPS WITHIN 6 SECONDS OF FINGER STICK. PT STATED THAT THE INRATIO METER WAS NOT IN CORRECT MODE WHEN FINGER-STICK WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136285 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 297457

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN