BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2992929 · Received February 28, 2013

    Report

    Report Number
    2027969-2013-00174
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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; INRATIO: 2.5, 1.5; LAB: 6.0. PT'S THERAPEUTIC RANGE: 2.0 - 3.0. TIME BETWEEN TESTS WAS ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87320 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO 100139 296416

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| UNSPECIFIED PAIN KILLERS