BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5237321 · Received November 19, 2015

    Report

    Report Number
    2027969-2015-00945
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Date of Event
    August 31, 2015
    Report Date
    October 23, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    Z-0880,0881,0882-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 200432. LOT #: REMOVED INRATIO PT/INR TEST STRIP LOT NUMBER AND INCLUDED SERIAL NUMBER OF THE MONITOR AS ABOVE. REMOVED THE MONITOR AS A CONCOMITANT MEDICAL PRODUCT AND ADDED THE INRATIO PT/INR TEST STRIPS. FOR 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. A STATISTICAL ANALYSIS OF THE IMPEDANCE CURVES ASSOCIATED WITH THE CUSTOMER'S RESULTS OF 2.2 AND 1.9 FOUND THAT THE CURVES EXHIBITED A WEAK SLOPE CHANGE. CAPA INVESTIGATION (CAPA(B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH WEAK SLOPE CHANGE CAN CAUSE DISCREPANT RESULTS. THE INRATIO MONITOR SOFTWARE MAY GENERATE AN INCORRECT OR DISCREPANT INR RESULT WHEN THE PATIENT SAMPLE EXHIBITS A WEAK-SLOPE CHANGE IMPEDANCE CURVE. THE CAPA INVESTIGATION HAS ALSO DETERMINED THAT CERTAIN PATIENT CONDITIONS CAN CONTRIBUTE TO WEAK SLOPE CHANGE IMPEDANCE CURVES. THERE ARE NO KNOWN PATIENT CONDITIONS PROVIDED BY THE CUSTOMER THAT WOULD LEAD TO THE OBSERVED WEAK SLOPE CHANGE. DONOR TESTING WAS NOT PURSUED DUE TO THE SOFTWARE ISSUE BEING IDENTIFIED AS THE ROOT CAUSE OF THE CUSTOMER'S DISCREPANT RESULTS. THE RETURNED MONITOR MET FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS. A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY OF THE REPORTED LOT WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT 367839A MEETS RELEASE CRITERIA. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATIONS. CAPA-(B)(4) IDENTIFIED IMPEDANCE CURVES WITH WEAK SLOPES AS POTENTIALLY LEADING TO DISCREPANT INR VALUES. FURTHER INVESTIGATION IS BEING PERFORMED UNDER CAPA-(B)(4) FOR THIS ISSUE.

    Description of Event or Problem · 1

    THE PATIENT SELF TESTER ALLEGED A VARIANCE BETWEEN INRATIO INR RESULTS AND THE LAB INR RESULTS. THE PATIENT SELF TESTER STATED THAT HE DID NOT KNOW THE EXACT DATES THE VARIANCE WITH THE LAB OCCURRED BUT IT WAS SOME TIME IN (B)(6) 2015. THE RESULTS WERE AS FOLLOWS: COMPARISON 1 INRATIO INR=1.9, LAB INR=4.2. COMPARISON 2 INRATIO INR=2.2, LAB INR=3.7. THE PATIENT'S THERAPEUTIC RANGE IS: 2.0-3.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767324 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 367839A

    Patients

    Seq Age Sex Outcome Treatment
    1