BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2926525 · Received January 17, 2013

    Report

    Report Number
    2027969-2013-00062
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PT SELF TESTER ALLEGING IMPRECISION INRATIO READINGS. INRATIO 4.3, RETEST 2.3 FIFTEEN MINUTES APART. PT WAS IN THE HOSPITAL NOT RELATED TO INRATIO AND RECEIVED BLOOD TRANSFUSION ONLY DAYS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26225 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN