BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2872506 · Received December 12, 2012

    Report

    Report Number
    2027969-2012-01690
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 20, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ALERE SAAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    DISCREPANT LOW RESULTS ON ONE PT, 1 LOT, 1 METER. INRATIO2: 3.2, LB: 5.2. TESTS PERFORMED SIMULTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAAN DIEGO, INC. 100139 282861

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN| METFORMIN| ZOCOR| PHENOBARBITAL| KOMBIGLYZE