BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 4428612 · Received January 16, 2015

    Report

    Report Number
    2027969-2015-00036
    Event Type
    Injury
    Date Received
    January 16, 2015
    Date of Event
    December 18, 2014
    Report Date
    December 19, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    Z00880, 0881, 0882-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION. 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 200431. 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 CUSTOMER'S COMPLAINT OF DISCREPANT LOW WAS NOT REPLICATED WITH THE RETURNED METER USING IN-HOUSE DONORS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECIFICATIONS AND NO NON-CONFORMANCES WERE DOCUMENTED. A REVIEW OF THE MONITOR MEMORY REVEALED THAT AN INRATIO INR RESULT OF 4.2 WAS OBTAINED ON (B)(6) 2014, HOWEVER, AT THE TIME OF THE COMPLAINT, THE CUSTOMER REPORTED A 4.6. PRODUCT SUPPORT WAS UNABLE TO DETERMINE IF THE 4.2 PRESENT IN THE MONITOR MEMORY WAS THE DISCREPANT RESULT THE CUSTOMER INTENDED TO REPORT. NO OTHER INRATIO RESULTS WERE OBTAINED ON (B)(6) 2014. IMPEDANCE CURVE ANALYSIS WAS PERFORMED ON THE RESULT OF 4.2. THE IMPEDANCE CURVE ASSOCIATED WITH THE RESULT OF 4.2 EXHIBITED A WEAK-SLOPE CHANGE. OUR CAPA INVESTIGATION ((B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH 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, THE CUSTOMER DID NOT REPORT ANY MEDICAL CONDITIONS THAT WOULD INTERFERE WITH THE TEST AND A HEMATOCRIT WAS NOT PROVIDED. A NOTIFICATION LETTER HAS BEEN SENT TO CUSTOMERS TO INFORM THEM OF THESE PATIENT CONDITIONS. FURTHER INVESTIGATION INTO THIS ISSUE WILL BE PURSUED UNDER CAPA-(B)(4).

    Description of Event or Problem · 1

    CALLER ALLEGING DISCREPANT LOW INRATIO READING: (B)(6) 2014 INRATIO 4.6; (B)(6) 2014 LAB 15 TWENTY-FOUR HOURS BETWEEN TESTS. PATIENT'S THERAPEUTIC RANGE 2-3. (B)(6) 2014 PATIENT SELF TESTER WAS HOSPITALIZED FOR BLEEDING FROM HEAD SCRATCH AFTER FALL. SCRATCH WOULD NOT STOP BLEEDING. PHYSICIAN STOPPED COUMADIN AND ADMINISTERED VITAMIN K. INR DOWN TO 6.0 ON (B)(6) 2014 LAB DRAW. PATIENT RELEASED FROM HOSPITAL ON (B)(6) 2014. DISCHARGE DIAGNOSIS UNAVAILABLE. NO FURTHER READINGS AVAILABLE. NO SUBSEQUENT TESTS ON INRATIO METER AFTER INITIAL 4.6 UNKNOWN QUANTITY OF VITAMIN K. PATIENT'S HOSPITAL STAY FROM (B)(6) 2014. HOME HEALTH NURSE STATED PATIENT WAS RESTING AT HOME. CURRENT MEDICAL CONDITION OR COUMADIN THERAPY UNKNOWN. NO ADDITIONAL INFORMATION PROVIDED OR AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39843 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200431 348121

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R METOPOROL| DIAZAPAN| NIACIN| INRATIO MONITOR SERAL # 123738859| SYNTHROID| AMIODARONE| TRIAMTERENE| FOLIC ACID| COUMADIN| B-COMPLEX