BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO2

    MDR report key: 2061082 · Received April 8, 2011

    Report

    Report Number
    2027969-2011-00735
    Event Type
    Other
    Date Received
    April 8, 2011
    Date of Event
    March 10, 2011
    Report Date
    April 8, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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) 2011, INRATIO: 4.4, LAB: 2.9 COUMADIN DOSAGE CHANGED. PT HAD A RESULT OF 4.4 ON INRATIO METER; COUMADIN DOSAGE WAS CHANGED. SAME DAY LAB RESULT CAME BACK TO SAY THAT PT WAS AT 2.9. PT'S THERAPEUTIC RANGE = 2.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 247452

    Patients

    Seq Age Sex Outcome Treatment
    1 Other