BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO 2 PT MONITORING SYSTEM

    MDR report key: 4433686 · Received January 20, 2015

    Report

    Report Number
    2027969-2015-00046
    Event Type
    Death
    Date Received
    January 20, 2015
    Date of Event
    December 8, 2014
    Report Date
    December 22, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    Z-0880, 0881, 0882-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS ASSOCIATED WITH THE COMPLAINT WERE RETURNED FOR INVESTIGATION. THE COMPLAINT OF A DISCREPANT LOW RESULT WAS NOT REPLICATED WHEN THE RETURNED MONITOR AND STRIPS WERE TESTED USING IN-HOUSE DONORS. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT DID NOT UNCOVER ANY NON-CONFORMANCES. THIS LOT MET RELEASE SPECIFICATIONS. THE IMPEDANCE CURVE ANALYSIS ASSOCIATED WITH THIS CASE 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. THE PATIENT HAD KIDNEY DISEASE AND RHEUMATOID ARTHRITIS AT THE TIME OF THE ALLEGED DISCREPANT RESULT. (B)(4) HAS IDENTIFIED KIDNEY DISEASE AND CHRONIC INFLAMMATION AS CONDITIONS THAT MAY CONTRIBUTE TO A DISCREPANT INR RESULT. A NOTIFICATION LETTER HAS BEEN SENT TO CUSTOMERS TO INFORM THEM OF THESE PATIENT CONDITIONS. A POSSIBLE ROOT CAUSE IS THE PATIENT CONDITIONS OF KIDNEY DISEASE AND RHEUMATOID ARTHRITIS WHICH MAY HAVE CONTRIBUTED TO AN IMPEDANCE CURVE THAT EXHIBITED A WEAK-SLOPE CHANGE. THE INRATIO MONITOR SOFTWARE MAY GENERATE AN INCORRECT OR DISCREPANT INR RESULT WHEN THE PATIENT SAMPLE EXHIBITS A WEAK-SLOPE CHANGE IMPEDANCE CURVE. FURTHER INVESTIGATION INTO THESE ISSUES WILL BE PURSUED UNDER (B)(4).

    Description of Event or Problem · 1

    ON (B)(6)2014, THE DISTRIBUTOR, ALERE HOME MONITORING, INC (AHM) REPORTED THE FOLLOWING TO ALERE SAN DIEGO, INC.:DATE INRATIO LAB(B)(6)2014 3.0 ---(B)(6) 2014 --- 7.9THERAPEUTIC RANGE: 2.0-3.0THE PATIENT SELF TESTER (PST) WAS ADMITTED INTO HOSPITAL ON (B)(6) 2014 DUE TO DIFFICULTY BREATHING AND EXTREME CONSTIPATION. PST ALSO HAD UNUSUAL BRUISING AND BLEEDING AT TIME OF ADMISSION. LAB INR AT TIME OF ADMISSION WAS 7.9. WHILE IN THE HOSPITAL, BLOOD CLOTS WERE FOUND IN THE PATIENT'S LEGS AND LUNGS. NO ADDITIONAL INFORMATION IS AVAILABLE. PATIENT DIED ON (B)(6)2014 DUE TO UNKNOWN CAUSES. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45781 INRATIO 2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H UNSPECIFIED HIGH BLOOD PRESSURE MEDICATION| WATER PILL| COUMADIN| STRIP PART #(B)(4), LOT 347476