BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1841531 · Received September 17, 2010

    Report

    Report Number
    2027969-2010-01487
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    NURSE REPORTS DISCREPANT METER RESULT COMPARED TO LAB FOR MULTIPLE PTS: PT #2, DATE: (B)(6) 2010, INRATIO: 5.2, LAB: 3.7. LONG TERM COUMADIN PT. PT'S TARGET THERAPEUTIC DOSE 2.0-3.0. PT'S HEMATOCRIT = 43.7%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 234590

    Patients

    Seq Age Sex Outcome Treatment
    1