BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 3905747 · Received May 27, 2014

    Report

    Report Number
    2027969-2014-00495
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014. INRATIO INR: 1.0 AND 1.8. THE TIME BETWEEN TESTING WAS FIVE (5) MINUTES. THERAPEUTIC RANGE 1.8 - 2.0 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
    311998 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 340746

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR SN: (B)(4)