BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 4704192 · Received April 17, 2015

    Report

    Report Number
    2027969-2015-00289
    Event Type
    Malfunction
    Date Received
    April 17, 2015
    Date of Event
    March 24, 2015
    Report Date
    April 2, 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
    WV, 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 200432 LOT#: REMOVED INRATIO PT/INR TEST STRIP LOT NUMBER AND INCLUDED SERIAL NUMBER OF MONITOR AS ABOVE. CONCOMITANT MEDICAL PRODUCTS: 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 MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. THE STRIPS ASSOCIATED WITH THE COMPLAINT WERE NOT RETURNED FOR INVESTIGATION. THE CUSTOMER'S COMPLAINT OF A CORRELATION ISSUE WAS NOT REPLICATED DURING IN-HOUSE INVESTIGATION. STRIP TESTING ON RETAIN STRIPS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE CURVES WERE ANALYZED STATISTICALLY TO DETERMINE IF THEY CONTAINED A WEAK SLOPE CHANGE. THE IMPEDANCE CURVES ASSOCIATED WITH THESE RESULTS EXHIBITED A WEAK SLOPE CHANGE. CAPA INVESTIGATION (CAPA-(B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH A WEAK SLOPE CHANGE CAN CAUSE DISCREPANT RESULTS. THE CAPA INVESTIGATION HAS ALSO DETERMINED THAT CERTAIN PATIENT CONDITIONS (E.G. LOW HEMATOCRIT, ELEVATED PLASMA PROTEINS) CAN CONTRIBUTE TO WEAK SLOPE CHANGE IMPEDANCE CURVES. HOWEVER, NO PATIENT MEDICAL CONDITIONS WERE IDENTIFIED IN THE COMPLAINT. A NOTIFICATION LETTER HAS BEEN SENT TO CUSTOMERS TO INFORM THEM OF THESE PATIENT CONDITIONS. THE CUSTOMER UTILIZED VENOUS SAMPLE ON THE INRATIO METER DURING TESTING ON (B)(6) 2015. THIS IS CONSIDERED OFF-LABEL USAGE AND COULD NOT BE RULED OUT AS A POSSIBLE CAUSE OF THE UNEXPECTED RESULT OBSERVED BY THE CUSTOMER. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES AND THE LOT MET RELEASE SPECIFICATION. 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.

    Additional Manufacturer Narrative · 1

    CORRECTIONS: THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. THE STRIPS ASSOCIATED WITH THE COMPLAINT WERE NOT RETURNED FOR INVESTIGATION. THE CUSTOMER'S COMPLAINT OF A CORRELATION ISSUE WAS NOT REPLICATED DURING IN-HOUSE INVESTIGATION. THE RETAIN STRIP TESTING ON THE RETURNED MONITOR MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. THE CUSTOMER UTILIZED VENOUS SAMPLE ON THE INRATIO METER DURING TESTING ON (B)(6) 2015. THIS IS CONSIDERED OFF-LABEL USAGE AND MAY HAVE CONTRIBUTED TO THE UNEXPECTED RESULT EXPERIENCED BY THE CUSTOMER. THE MONITOR MEMORY WAS REVIEWED. THE INRATIO INR RESULT OF 1.9 WAS FOUND ON THE REPORTED DATE OF OCCURRENCE. AN INRATIO INR RESULT OF >7.5 WAS FOUND ON THE REPORTED DATE OF OCCURENCE, NOT 7.5 AS REPORTED. THE IMPEDANCE CURVES ASSOCIATED WITH THE CUSTOMER'S RESULTS OF 1.9 AND >7.5 WERE STATISTICALLY ANALYZED TO DETERMINE IF THEY CONTAINED A WEAK SLOPE CHANGE. THE IMPEDANCE CURVE ASSOCIATED WITH THE INR RESULT >7.5 APPEARS NORMAL IN SHAPE AND DOES NOT EXHIBIT CHARACTERISTICS OF A WEAK SLOPE CHANGE. THE IMPEDANCE CURVE ASSOCIATED WITH THE INR RESULT 1.9 EXHIBITED A WEAK SLOPE CHANGE. CAPA INVESTIGATION ((B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH A WEAK SLOPE CHANGE CAN CAUSE DISCREPANT RESULTS. THE CAPA INVESTIGATION HAS ALSO DETERMINED THAT CERTAIN PATIENT CONDITIONS (E.G. LOW HEMATOCRIT, ELEVATED PLASMA PROTEINS) CAN CONTRIBUTE TO WEAK SLOPE CHANGE IMPEDANCE CURVES. HOWEVER, NO PATIENT MEDICAL CONDITIONS WERE IDENTIFIED IN THE COMPLAINT THAT WOULD INTERFERE WITH THE TEST. A NOTIFICATION LETTER HAS BEEN SENT TO CUSTOMERS TO INFORM THEM OF THESE PATIENT CONDITIONS. FURTHER INVESTIGATION IS DOCUMENT UNDER (B)(4).

    Description of Event or Problem · 1

    THE CALLER ALLEGED VARIANCE BETWEEN THE INRATIO INR RESULTS IN COMPARISON TO THE LABORATORY INR RESULTS. RESULTS ARE AS FOLLOWS: (B)(6). THERAPEUTIC RANGE: 2.0 - 3.0 THE TIME BETWEEN TESTING, ON (B)(6) 2015, WAS FIVE (5) MINUTES. VENOUS BLOOD WAS USED WHEN TESTING ON THE INRATIO DEVICE. THIS IS CONSIDERED OFF LABEL USE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257262 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 364994A

    Patients

    Seq Age Sex Outcome Treatment
    1 SPIRONOLACTONE 25MG| WARFARIN 7.5MG M/W/F AND 5MG T/TH/SA/SU| AMIODARONE 200MG DAILY| LASIX 80MG TWICE DAILY| METOPROLOL 25MG TWICE DAILY| LOSARTAN 25MG| PEPCID| INRATIO PT/INR TEST STRIPS (B)(4), LOT # 364994A| SYMBICORT| VITAMIN D| LORATADINE 10MG| ESCITALOPRAM 10MG| MELATONIN 1MG| INRATIO MONITOR SN (B)(4)