BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5034792 · Received August 27, 2015

    Report

    Report Number
    2027969-2015-00618
    Event Type
    Injury
    Date Received
    August 27, 2015
    Date of Event
    July 24, 2015
    Report Date
    August 4, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    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 200431 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 PRODUCT ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. THERAPEUTIC AND NORMAL DONOR TESTING WAS PERFORMED USING THE RETURNED INRATIO MONITOR SN: (B)(4) UTILIZING RETAIN STRIPS LN: 362444A. THE COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE INVESTIGATION. THE RETURNED MONITOR MET FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING INVESTIGATION. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. THERE WERE NO PRODUCT DEFICIENCIES FOUND FOR LOT 362444A. CAPA INVESTIGATION ((B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH WEAK SLOPE CHANGE CAN CAUSE DISCREPANT RESULTS. THE IMPEDANCE CURVE ANALYSIS ASSOCIATED WITH THE 2.8 INRATIO RESULT FOUND THAT THE CURVE EXHIBITED A WEAK SLOPE CHANGE. THE CAPA INVESTIGATION HAS ALSO DETERMINED THAT CERTAIN PATIENT CONDITIONS (E.G. LOW HEMATOCRIT, SEPSIS) CAN CONTRIBUTE TO WEAK SLOPE CHANGE IMPEDANCE CURVES. THE PATIENT HAD RHEUMATOID ARTHRITIS AT THE TIME OF THE ALLEGED DISCREPANT RESULT. (B)(4) HAS IDENTIFIED 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. FURTHER INVESTIGATION WAS PERFORMED UNDER (B)(4).

    Description of Event or Problem · 1

    THE CALLER ALLEGED A VARIANCE BETWEEN THE INRATIO INR RESULT AND THE LABORATORY INR RESULT. (B)(6) 2015: HISTORICAL INRATIO INR RESULT=2.0. ON (B)(6) 2015, THE PATIENT TESTED ON THE INRATIO AND OBTAINED AN INR OF 2.8 WHICH WAS WITHIN THE PATIENT'S THERAPEUTIC RANGE OF 1.5 - 3.0. A LABORATORY INR COMPARISON WAS PERFORMED ON (B)(6) 2015 DUE TO THE RECOMMENDATION OF HAVING PERIODIC LABORATORY COMPARISONS DONE AS MENTIONED IN THE MEDICAL DEVICE CORRECTION LETTER SENT IN DECEMBER OF 2014. ON (B)(6) 2015, THE LABORATORY INR AND THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2015, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE CALLER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. NOTE: THE PATIENT HAS A MEDICAL HISTORY OF RHEUMATOID ARTHRITIS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE LABORATORY INR WAS 9.0 AND THE PATIENT WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568140 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200431 362444A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization OTHER UNSPECIFIED MEDICATIONS