BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3102673 · Received May 1, 2013

    Report

    Report Number
    2027969-2013-00347
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO INR RESULTS IN COMPARISON TO THE LAB INR RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2013; INRATIO INR: 1.2; LAB INR: 2.3. TESTING WAS PERFORMED SIMULTANEOUSLY. THERAPEUTIC RANGE WAS NOT PROVIDED FOR THE PT. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190810 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100139 303232

    Patients

    Seq Age Sex Outcome Treatment
    1