BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3013025 · Received March 1, 2013

    Report

    Report Number
    2027969-2013-00179
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS WHEN COMPARED TO THE PHYSICIAN'S RESULTS WITH SAME METER BUT DIFFERENT STRIPS. RESULTS AS FOLLOWS: DATE (B)(6) 2013, PT INRATIO INR 1.0, PHYSICIAN INRATIO INR 2.2. THE TIME BETWEEN TESTING WAS WITHIN ONE HOUR. THERAPEUTIC RANGE WAS NOT PROVIDED FOR THE PT. THE LOT NUMBER OF THE PHYSICIAN'S STRIPS WAS NOT PROVIDED. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90316 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 291557

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN