BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 3871945 · Received April 17, 2014

    Report

    Report Number
    2027969-2014-00350
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 12, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING DATA WAS PERFORMED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCTS PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INCLUDE RETURN TESTING, IMPROPER USE OF THE METER WAS IDENTIFIED IN THE COMPLAINT. ADDITIONALLY, THE CUSTOMER HAS LUPUS. THE CUSTOMER'S BLOOD SAMPLE MAY HAVE INTERFERED WITH THE COAGULATION TEST. THIS COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECIFICATIONS AND NO NON-CONFORMANCES WERE DOCUMENTED. NO FURTHER INVESTIGATION WILL BE PERFORMED 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 INRATIO RESULTS. PATIENT COULD NOT CONFIRM THE TIME DIFFERENCE BETWEEN REPEAT TESTS ON (B)(6). THERAPEUTIC RANGE: 2.5-3.5. PATIENTS NORMAL COUMADIN DOSE IS 5 MG 5 DAYS/WEEK WITH 7.5 MG 2 DAYS/WEEK. ON (B)(6) PATIENTS DOCTOR CHANGED COUMADIN DOSE TO 7.5 MG 3 DAYS/WEEK AND 5 MG 4 DAYS/WEEK. PATIENT SELF TESTER PRICKS FINGER BEFORE INSERTING THE STRIP TO PERFORM THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236158 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 332436

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR: SERIAL NUMBER (B)(4)| COUMADIN