BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2155766 · Received June 6, 2011

    Report

    Report Number
    2027969-2011-01248
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING. ADD'L LOT # 241836.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER: DATE: (B)(6) 2011, INRATIO: 3.3, (LOT # 241836). DATE: (B)(6) 2011, INRATIO: 2.9, (LOT # 248203). PT'S TARGET THERAPEUTIC RANGE IS 2.0-3.0. METER RESULTS DONE MINUTES APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 248203

    Patients

    Seq Age Sex Outcome Treatment
    1