BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3862872 · Received February 19, 2014

    Report

    Report Number
    2027969-2014-00136
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. CUSTOMER ALSO DID NOT PROVIDE LOT NUMBERS. UNABLE TO PERFORM FURTHER INVESTIGATION WITHOUT ADDITIONAL INFORMATION. RESULTS OF THE QUERY OF SIMILARLY INCIDENTS IN THE COMPLAINT SYSTEM FOR THIS TREND CODE DID NOT INDICATE A MANUFACTURING ISSUE. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT LOW INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014, INRATIO INR: 1.6, LABORATORY INR: 4.7. THE TIME BETWEEN TESTING WAS WITHIN THREE (3) HOURS. THERAPEUTIC RANGE WAS NOT PROVIDED FOR THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104350 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G2

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR| COUMADIN