BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3832517 · Received March 17, 2014

    Report

    Report Number
    2027969-2014-00239
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 27, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT LOW INRATIO2 INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014, INRATIO INR: 1.4, LABORATORY INR: 2.1, THERAPEUTIC RANGE: 2.0 - 3.0. THE TIME BETWEEN TESTING WITHIN ONE (1) HOUR. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157097 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G2 335553

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN 5-7.5MG DEPENDING ON INR RESULTS| INRATIO MONITOR| UNSPECIFIED ANTI-FUNGAL MEDICATION