BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO/INRATIO2 TEST STRIPS

    MDR report key: 3843048 · Received March 14, 2014

    Report

    Report Number
    2027969-2014-00230
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 7, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    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. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. SINCE THE PRODUCT WAS PERFORMED DURING AN IN-HOUSE INVESTIGATION. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECIFICATIONS AND NO NON-CONFORMANCES WERE DOCUMENTED. NO FURTHER INVESTIGATION WAS PURSUED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014, INRATIO INR: 1.5, LABORATORY INR: 2.9. THERAPEUTIC RANGE: 2.5 - 3.5. THE TIME BETWEEN TESTING WAS TWO (2) HOURS. REPORTEDLY, THE FINGER WAS "MILKED" AFTER THE FINGER STICK. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154077 INRATIO/INRATIO2 TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 332434

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO2 MONITOR: SN (B)(4)