BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4949701 · Received July 29, 2015

    Report

    Report Number
    2027969-2015-00544
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    June 29, 2015
    Report Date
    June 30, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION UPDATE: THE PRODUCTS ASSOCIATED WITH THE COMPLAINT WERE RETURNED FOR INVESTIGATION. THE CUSTOMER'S COMPLAINT OF DISCREPANT HIGH RESULTS WAS NOT CONFIRMED DURING IN-HOUSE TESTING. RETURNED AND RETAIN STRIPS TESTED ON THE RETURNED METER MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE RETURNED METER MET FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING INVESTIGATION. ALTHOUGH RELEVANT NCS WERE NOTED IN BATCH RECORD, IT DID NOT AFFECT THE FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION OF A DEFICIENCY WITH THE STRIPS AND ADDITIONAL CORRECTIVE ACTIONS WERE NOT REQUIRED. THE IMPEDANCE CURVE ANALYSIS ASSOCIATED WITH THIS CASE FOUND TWO IMPEDANCE CURVES WHICH EXHIBITED A WEAK SLOPE CHANGE. CAPA INVESTIGATION (CAPA-(B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH WEAK SLOPE CHANGE CAN CAUSE DISCREPANT RESULTS. THE INRATIO METER SOFTWARE MAY GENERATE AN INCORRECT OR DISCREPANT INR RESULT WHEN THE PATIENT SAMPLE EXHIBITS A WEAK-SLOPE CHANGE IMPEDANCE CURVE. THE CAPA INVESTIGATION HAS ALSO DETERMINED THAT CERTAIN PATIENT CONDITIONS CAN CONTRIBUTE TO WEAK SLOPE CHANGE IMPEDANCE CURVES. THE CUSTOMER DID NOT REPORT TO HAVE A MEDICAL CONDITION THAT WOULD INTERFERE WITH THE TEST. ALTHOUGH TWO TECHNIQUE ISSUES WERE ALSO IDENTIFIED IN THE COMPLAINT, ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. AN IMPEDANCE CURVE WITH WEAK-SLOPE CHANGE HAS BEEN IDENTIFIED IN CAPA-(B)(4) TO CONTRIBUTE TO A POTENTIAL DISCREPANT RESULT. FURTHER INVESTIGATION IS BEING PERFORMED UNDER CAPA-(B)(4) FOR THIS ISSUE.

    Description of Event or Problem · 1

    CALLER ALLEGING DISCREPANT INRATIO VALUES. PATIENT'S THERAPEUTIC RANGE: 2.5 - 3.5. (B)(6) 2015 INRATIO = 4.7; REPEAT INRATIO = 6.9; 2ND REPEAT INRATIO = 7.5. TIME BETWEEN INRATIO TESTS 15 MINUTES BETWEEN EACH TEST. (B)(6) 2015 LAB = 3.1. PATIENT HELD WARFARIN MEDICATION ON (B)(6) 2015. UNKNOWN IF PHYSICIAN ORDERED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494759 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 365984A

    Patients

    Seq Age Sex Outcome Treatment
    1