BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 4484796 · Received February 4, 2015

    Report

    Report Number
    2027969-2015-00082
    Event Type
    Malfunction
    Date Received
    February 4, 2015
    Date of Event
    January 7, 2015
    Report Date
    January 14, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    Z-0880, 0881, 0882-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. DEVICE AVAILABLE FOR EVALUATION? CHANGED FROM "NO" TO "YES" AND DATE RETURNED ENTERED. 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. DEVICE EVALUATED BY MANUFACTURER? CHANGED FROM "NOT RETURNED TO MANUFACTURER" TO "YES" AND EVALUATION SUMMARY ATTACHED. LABELED FOR SINGLE USE?: CHANGED FROM "YES" TO "NO" SINCE THE MONITOR IS NOT A SINGLE USE DEVICE. (B)(4). UPDATE: INVESTIGATION/CONCLUSION: THE MONITOR ASSOCIATED WITH THE COMPLAINT 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 DURING IN-HOUSE TESTING. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THERE WERE NO ISSUES RELATED TO THIS COMPLAINT. THE IMPEDANCE CURVE ANALYSIS PERFORMED ON THE RESULT OF 2.0 ON 01/07/2015 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. HOWEVER, THE CUSTOMER DID NOT REPORT ANY MEDICAL CONDITIONS THAT WOULD INTERFERE WITH THE TEST AND A HEMATOCRIT AT THE TIME OF THE DISCREPANCY WAS NOT PROVIDED. A NOTIFICATION LETTER HAS BEEN SENT TO CUSTOMERS TO INFORM THEM OF THESE PATIENT CONDITIONS. FURTHER INVESTIGATION IS BEING PERFORMED UNDER CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    AS OF 02/17/2015, THE DEVICE HAS NOT BEEN RETURNING FOR FURTHER INVESTIGATION. 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 WAS PERFORMED. THE RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THERE WERE NO ISSUES RELATED TO THIS COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. IN THE EVENT THAT THE PRODUCT RETURNS, AN EVALUATION OF THE RETURNED PRODUCT WILL BE PERFORMED. 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 DISCREPANT LOW INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2015; INRATIO INR: 2.0; LABORATORY INR: 5.8. THERAPEUTIC RANGE: 2.0 - 3.0. THE TIME BETWEEN TESTING WAS WITHIN ONE (1) HOUR. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79872 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 358566

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN 4MG DAILY| INRATIO MONITOR, SN (B)(4)