BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1851566 · Received September 27, 2010

    Report

    Report Number
    2027969-2010-01530
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    July 29, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    021923
    Removal / Correction Number
    NI
    Adverse Event
    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

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. PT'S COUMADIN DOSE WAS DECREASED FOLLOWING RESULTS ON (B)(6) 2010. ON (B)(6) 2010, RESULTS WERE PERFORMED WITH NEW STRIP LOT #234526.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 234526

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention