BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5377894 · Received January 19, 2016

    Report

    Report Number
    2027969-2016-00037
    Event Type
    Injury
    Date Received
    January 19, 2016
    Date of Event
    December 27, 2015
    Report Date
    December 30, 2015
    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
    CT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    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. REMOVED THE MONITOR AS A CONCOMITANT MEDICAL PRODUCT AND ADDED THE INRATIO PT/INR TEST STRIPS 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; HOWEVER, NO TESTING STRIPS WERE RETURNED. FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED MONITOR WITH PASSING RESULTS. RECOVERED IMPEDANCE CURVES ASSOCIATED WITH TWO OF THE CUSTOMER'S REPORTED INRATIO INR RESULTSON 12/11/2015 AND 12/27/2015 EXHIBITED A WEAK-SLOPE CHANGE. WEAK-SLOPE CHANGES ARE KNOWN TO CONTRIBUTE TO DISCREPANT RESULTS. THIS ISSUE IS RELATED TO THE ALGORITHM SOFTWARE ON THE MONITOR AND WAS ADDRESSED IN INTERNAL (B)(4). DONOR/RETAIN STRIP TESTING ON THE MONITOR WAS NOT NECESSARY DUE TO WEAK SLOPE CHANGES IDENTIFIED AS THE CAUSE OF CUSTOMER DISCREPANT RESULTS, THE CUSTOMER USING EXPIRED STRIPS, AND EXTENSIVE IN-HOUSE TESTING ON THE REPORTED LOT DONOR. A REVIEW OF THE IN-HOUSE TESTING HISTORY FOR THE REPORTED LOT WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT 340746 MET RELEASE CRITERIA. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATIONS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. THE CUSTOMER USED EXPIRED STRIPS, THIS MAY CONTRIBUTE TO INACCURATE TEST RESULTS. FURTHER INVESTIGATION WAS PERFORMED UNDER (B)(4) FOR THIS ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    THE END USER'S THERAPEUTIC RANGE WAS 2.0 - 3.0. REPORTEDLY, THE END USER WAS USING TESTING STRIPS THAT EXPIRED IN JUNE 2015. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    THE END USER'S DAUGHTER ALLEGED A VARIANCE BETWEEN THE INRATIO INR RESULTS AND THE LABORATORY INR RESULT. ON (B)(6) 2015, THE END USER'S DAUGHTER HELPED THE PATIENT PERFORM A SELF TEST ON HIS INRATIO DEVICE AND RECEIVED AN INR OF 2.2. ADDITIONALLY, SHE NOTED THAT THE PREVIOUS TWO (2) INRATIO INR RESULTS FROM (B)(6) 2015 WERE ALSO 2.2. THE PATIENT'S WARFARIN HAD NOT BEEN CHANGED. THE DAUGHTER REPORTED THAT THE PATIENT WAS VERY WEAK, VOMITING AND HIS ABDOMEN APPEARED DISTENDED. THIS WAS REPORTED TO THE PHYSICIAN AND THE PATIENT WAS INSTRUCTED TO GO TO THE EMERGENCY ROOM WHERE HE WAS HOSPITALIZED FOR INTERNAL BLEEDING. THE LABORATORY INR WAS 14.0. TREATMENT INCLUDED BLOOD AND PLASMA TRANSFUSION IN ADDITION TO VITAMIN K ADMINISTRATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2015 IN STABLE CONDITION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35570 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 340746

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R