BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2100147 · Received May 12, 2011

    Report

    Report Number
    2027969-2011-01065
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    March 29, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB FOR PT #2. RESULTS AS FOLLOWS: DATES: (B)(6) 2011, INRATIO: 1.8, LAB: 4.95. TESTS DONE BACK TO BACK. PT'S THERAPEUTIC RANGE IS: 2.3. PT IS ON COUMADIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 240450

    Patients

    Seq Age Sex Outcome Treatment
    1 NI