BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 4274171 · Received November 6, 2014

    Report

    Report Number
    2027969-2014-00997
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    October 13, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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. 510K#: REMOVED THE INRATIO PT/INR TEST STRIP 510K# K092987 AND ADDED K072727 TO REFLECT THE INRATIO2 PT MONITORING SYSTEM. INVESTIGATION/CONCLUSION: THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. THE COMPLAINT OF A DISCREPANT LOW RESULT WAS NOT REPLICATED WHEN THE RETURNED MONITOR AND RETAIN 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. IMPEDANCE CURVE ANALYSIS WAS PERFORMED ON THE REPORTED INRATIO INR RESULTS. THE IMPEDANCE CURVE ASSOCIATED WITH THIS CASE 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 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 HAS A HISTORY OF CANCER AND WAS HOSPITALIZED FOR A WOUND IN GROIN AT THE TIME FOR THE ALLEGED DISCREPANT RESULT. CAPA-(B)(4) HAS IDENTIFIED CANCER AS A CONDITION THAT MAY CONTRIBUTE TO A DISCREPANT INR RESULT. A NOTIFICATION HAS BEEN SENT TO CUSTOMERS TO INFORM THEM OF THESE PATIENT CONDITIONS. A POSSIBLE ROOT CAUSE IS THE PATIENT CONDITION OF CANCER WHICH MAY HAVE CONTRIBUTED TO AN IMPEDANCE CURVE THAT EXHIBITED WEAK-SLOPE CHANGE. THE INRATIO METER 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 CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT LOW INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. ON (B)(6) 2014, THE INRATIO INR WAS 2.6 AND THE LABORATORY INR WAS 11.9. THE PATIENT'S THERAPEUTIC RANGE WAS 2.0 - 3.0. THE TIME BETWEEN TESTING WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED DUE TO A LEFT GROIN WOUND, BLEEDING OF WOUND AND HIGH LABORATORY INR. DURING THE HOSPITALIZATION, THE PATIENT WAS ADMINISTERED VITAMIN KI, COUMADIN, PAIN MEDICATION AND UNSPECIFIED ANTIBIOTICS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. THE INRATIO INR ON (B)(6) 2014 WAS 1.5. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713112 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 350587

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R COUMADIN| INRATIO MONITOR: SN (B)(4)