BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO/INRATI02 TEST STRIPS

    MDR report key: 3853150 · Received April 2, 2014

    Report

    Report Number
    2027969-2014-00288
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 16, 2014
    Report Date
    March 17, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, RETAIN TESTING ON IN RATIO STRIPS WAS PERFORMED DURING AN IN-HOUSE INVESTIGATION. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCTS PERFORMED AS EXPECTED AND PRODUCT DEFICIENCIES WERE NOT OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECIFICATIONS AND NO NON-CONFORMANCES WERE DOCUMENTED. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. 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 HIGH IN RATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE - (B)(6) 2014, INRATIO INR: 7.5, LABORATORY INR: 3.0. THE TIME BETWEEN TESTING AND PT THERAPEUTIC RANGE WAS NOT PROVIDED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, CALLER WAS UNABLE TO PROVIDE TECHNIQUE, STRIP OR PATIENT INFORMATION AS THEY DID NOT PERFORM THE TEST. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197031 INRATIO/INRATI02 TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 310821

    Patients

    Seq Age Sex Outcome Treatment
    1