BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATION PT/INR TEST STRIPS

    MDR report key: 3901917 · Received May 7, 2014

    Report

    Report Number
    2027969-2014-00406
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014. INRATIO INR 1.8 AND 3.9. THE TIME BETWEEN TESTING WAS WITHIN MINUTES. THERAPEUTIC RANGE 2.5-3.0 FOR THE PATIENT. THERE WAS NOT PATIENT ADVERSE EVENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276814 INRATION PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 334472

    Patients

    Seq Age Sex Outcome Treatment
    1 SYNTHROID| INRATIO MONTIOR: SN (B)(4)| COUMADIN