BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3243030 · Received July 18, 2013

    Report

    Report Number
    2027969-2013-00583
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED BUT HAS NOT YET BEEN RECEIVED. INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO INR RESULTS BETWEEN TWO STRIP LOTS; HOWEVER, ONLY ONE STRIP LOG NUMBER WAS PROVIDED. RESULTS AS FOLLOWS: DATE: (B)(6) 2013; INRATIO INR: 2.3 AND 3.6. THE TIME BETWEEN TESTING WAS WITHIN MINUTES ON DIFFERENT FINGERS. THERAPEUTIC RANGE REPORT IS 3.0 - 3.5 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
    336534 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 294386

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN ALTERNATING 2.5 MG AND 5 MG DOSES