BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 2141095 · Received June 15, 2011

    Report

    Report Number
    2027969-2011-01352
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" (B)(6) 2011 INR = 1.6; (B)(6) 2011 INR = 1.6. CALLER REPORTED THAT THE PT'S INR WAS 1.6 TWO WEEKS IN A ROW EVEN AFTER COUMADIN DOSE WAS INCREASED. CAREGIVER NOTICED BLOOD IN THE PT'S STOOL. THERAPEUTIC RANGE: 2.5-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 247451

    Patients

    Seq Age Sex Outcome Treatment
    1 Other