BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2820281 · Received October 31, 2012

    Report

    Report Number
    2027969-2012-01581
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. RESULTS AS FOLLOWS: DATE: (B)(6) 2012, INRATIO: 4.5, LAB: 2.2. PT'S THERAPEUTIC RANGE: 2-3 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 287164

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN