BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 2061043 · Received April 4, 2011

    Report

    Report Number
    2027969-2011-00699
    Event Type
    Other
    Date Received
    April 4, 2011
    Date of Event
    March 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: 4.30. DATE: (B)(6) 2011, INRATIO: 6.3, LAB: 1.81. NURSE DECREASED COUMADIN DOSE. NURSE ALSO REPORTED QC ERRORS ON ANOTHER PATIENT 2 DAYS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 246446

    Patients

    Seq Age Sex Outcome Treatment
    1 Other