BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3853725 · Received April 10, 2014

    Report

    Report Number
    2027969-2014-00319
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/ CONCLUSION: THE CUSTOMER REPORTED A DISCREPANT HIGH INRATIO INR RESULT DURING TESTING. IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE RETAIN TESTING WAS PERFORMED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCTS PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE CUSTOMER WAS USING CAPILLARY TUBES DURING SAMPLE COLLECTION AND APPLICATION ON THEIR INRATIO2 PROFESSIONAL STRIPS. CAPILLARY TUBES HAVE NOT BEEN VALIDATED FOR THE USE ON THE PRODUCT AND CANNOT BE RULED OUT AS A POSSIBLE ROOT CAUSE FOR THE UNEXPECTED RESULTS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECIFICATIONS AND NO NON-CONFORMANCE'S WERE DOCUMENTED. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. BASED ON THE INFORMATION AVAILABLE., THER 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 INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014, INRATIO INR: >7.5, LABORATORY INR: 3.2. THERAPEUTIC RANGE: 2.0-2.5. THE TIME BETWEEN TESTING WAS WITHIN TWENTY (20) MINUTES. REPORTEDLY, THE CUSTOMER WAS USING CAPILLARY TUBES DURING SAMPLE COLLECTION AND APPLICATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELAE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217565 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 99008G2 334572

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATION METER, SN: UNKNOWN| COUMADIN