BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3023126 · Received February 26, 2013

    Report

    Report Number
    2027969-2013-00168
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) 2013; INRATIO2: 1.0; LAB: 2.6. DATE: (B)(6) 2013; INRATIO2: 1.3; LAB: 3.33. LESS THAN 1 HR BETWEEN COMPARISON TESTS. THERAPEUTIC RANGE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83141 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC 100139 291556

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN