BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4626702 · Received March 24, 2015

    Report

    Report Number
    2027969-2015-00208
    Event Type
    Malfunction
    Date Received
    March 24, 2015
    Date of Event
    March 5, 2015
    Report Date
    March 5, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Removal / Correction Number
    Z-0880, 0881, 0882-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    CORRECTIONS: BRAND NAME: REMOVED INRATIO PT/INR TEST STRIPS (AS THE COMPLAINT DEVICE) AND ADDED THE INRATIO2 PT MONITORING SYSTEM (MONITOR). MODEL #: REMOVED INRATIO PT/INR TEST STRIP AND ADDED THE MONITOR MODEL (B)(4). LOT#: REMOVED INRATIO PT/INR TEST STRIP LOT NUMBER AND INCLUDED SERIAL NUMBER OF MONITOR AS ABOVE. REMOVED THE MONITOR AS A CONCOMITANT MEDICAL PRODUCT AND ADDED THE INRATIO PT/INR TEST STRIPS. THE 510K#: REMOVED THE INRATIO PT/INR TEST STRIP 510K# K092987 AND ADDED K072727 TO REFLECT THE INRATIO2 PT MONITORING SYSTEM. LABELED FOR SINGLE USE?: CHANGED FROM "YES" TO "NO" SINCE THE MONITOR IS NOT A SINGLE USE DEVICE. USAGE OF DEVICE: CHANGED FROM "UNKNOWN" TO "REUSE" SINCE THE MONITOR IS NOT A SINGLE USE DEVICE. INVESTIGATION/CONCLUSION: THE INRATIO MONITOR WAS RETURNED FOR INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE INVESTIGATION. INVESTIGATION OF THE RETURNED MONITOR USING RETAIN STRIPS DID NOT UNCOVER ANY DEFICIENCIES. THE MONITOR AND STRIPS CONTINUE TO MEET SPECIFICATION AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND NO ISSUES WERE RELATED TO THIS COMPLAINT. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE CANNOT BE RULED OUT AS A POSSIBLE ROOT CAUSE FOR THE UNEXPECTED RESULTS. THE IMPEDANCE CURVE ANALYSIS, ASSOCIATED WITH THIS CASE, FOUND THE CURVE EXHIBITED A WEAK SLOPE CHANGE. OUR CAPA INVESTIGATION (CAPA-(B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH WEAK SLOPE CHANGE CAN CAUSE DISCREPANT RESULTS. THE INRATIO MONITOR 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 (E.G. LOW HEMATOCRIT, SEPSIS) CAN CONTRIBUTE TO WEAK SLOPE CHANGE IMPEDANCE CURVES. THERE WERE NO PATIENT CONDITIONS PROVIDED, BY THE CUSTOMER, TO DETERMINE IF THESE LED TO THE WEAK SLOPE CHANGE OBSERVED. FURTHER INVESTIGATION INTO THIS ISSUE IS BEING PERFORMED UNDER CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTIONS: BRAND NAME: REMOVED INRATIO2 PT MONITORING SYSTEM (AS THE COMPLAINT DEVICE) AND ADDED THE INRATIO PT/INR TEST STRIPS MODEL #: REMOVED INRATIO2 PT MONITORING SYSTEM, MODEL # AND SERIAL #; ADDED THE INRATIO PT/INR TEST STRIP, MODEL # AND LOT #. CONCOMITANT MEDICAL PRODUCTS: REMOVED THE INRATIO PT/INR TEST STRIPS AS A CONCOMITANT MEDICAL PRODUCT AND ADDED THE MONITOR. THE 510K#: REMOVED THE INRATIO2 PT MONITORING SYSTEM K072727 AND ADDED INRATIO PT/INR TEST STRIP 510K# K092987. LABELED FOR SINGLE USE?: CHANGED FROM "NO" TO "YES" SINCE THE STRIPS ARE A SINGLE USE DEVICE. (B)(4). REMOVE RECALL NUMBER 0 USAGE OF DEVICE: CHANGED FROM "REUSE" TO "UNKNOWN" SINCE THE STRIPS ARE A SINGLE USE DEVICE INVESTIGATION/CONCLUSION REVISED DUE TO FURTHER INVESTIGATION INTO THE IMPEDANCE CURVE ON THE MONITOR. THE MONITOR ASSOCIATED WITH THE COMPLAINT, WHICH SHOULD BE LISTED AS THE CONCOMITANT MEDICAL PRODUCT, WAS RETURNED FOR INVESTIGATION. THE TESTING STRIPS WERE NOT RETURNED. THE IMPEDANCE CURVE, OF THE MONITOR, WAS ANALYZED STATISTICALLY TO DETERMINE IF IT EXHIBITED A WEAK SLOPE CHANGE. THE IMPEDANCE CURVE ANALYSIS ASSOCIATED WITH THIS CASE FOUND THE CURVE DID NOT EXHIBIT A WEAK-SLOPE CHANGE. THE IMPEDANCE CURVE APPEARS NORMAL IN SHAPE AND DOES NOT EXHIBIT CHARACTERISTICS OF A WEAK-SLOPE CHANGE CURVE. CERTAIN RELEVANT CONDITIONS (E.G. LOW HEMATOCRIT, SEPSIS) CAN CONTRIBUTE TO DISCREPANT INR RESULTS. THE CUSTOMER REPORTED THAT THEY DO NOT HAVE ANY KNOWN MEDICAL CONDITIONS THAT WOULD INTERFERE WITH THE TEST. A NOTIFICATION LETTER HAS BEEN SENT TO CUSTOMERS TO INFORM THEM OF THESE PATIENT CONDITIONS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THERE WERE NO ISSUES RELATED TO THIS COMPLAINT. THE COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE INVESTIGATION. INVESTIGATION OF THE RETURNED MONITOR USING RETAIN STRIPS DID NOT UNCOVER ANY DEFICIENCIES. THE MONITOR AND STRIPS CONTINUE TO MEET SPECIFICATION AND NO PRODUCT DEFICIENCIES WERE OBSERVED. ALTHOUGH A IMPROPER TECHNIQUES WERE IDENTIFIED, A ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE CALLER ALLEGED A DISCREPANT HIGH INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2015, INRATIO INR: >7.5, LABORATORY INR: 3.2. THERAPEUTIC RANGE: 2.0 - 3.0. THE TIME BETWEEN TESTING WAS TWO (2) HOURS. THE CUSTOMER REPORTED IMPROPER TECHNIQUES WHEN PERFORMING THE INRATIO TESTING BY NOT IMMEDIATELY APPLYING THE SAMPLE AFTER THE FINGER STICK AND TOUCHING HIS FINGER TO THE SAMPLE WELL. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196252 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 354045

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN 4.5 MG M/F AND 3 MG TU/TH/SA/SU| INRATIO MONITOR, (B)(4)| INRATIO MONITOR, (B)(4)| INRATIO PT/INR TEST STRIPS 100071, LOT# 354045