BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1982562 · Received January 11, 2011

    Report

    Report Number
    2027969-2011-00066
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2010, INRATIO: 1.4, RETEST INRATIO: 3.X. CUSTOMER UNSURE OF THE DECIMAL VALUE FOR SECOND RESULT. RESULTS DONE "WITHIN A COUPLE OF MINS" OF EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 235739

    Patients

    Seq Age Sex Outcome Treatment
    1