BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 1905851 · Received November 9, 2010

    Report

    Report Number
    2027969-2010-01902
    Event Type
    Other
    Date Received
    November 9, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. RESULTS AS FOLLOWS:" DATE: (B)(6) 2010; INRATIO: 2.7; LAB: 12.6. PT WAS ADMITTED AND DISCHARGED (LAB RESULT WAS CONFIRMED BY (B)(6) HOSPITAL WHICH RESULTED >9.9 INR). VITAMIN K INTAKE WHILE AT HOSPITAL; CHANGE COUMADIN DOSE. OTHER RECENT DISCREPANT DATA FROM SEVERAL PTS (METER VS. LAB). NO SELF-TEST WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 234586

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O