BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5035456 · Received August 27, 2015

    Report

    Report Number
    2027969-2015-00627
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    July 15, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. SINCE NO STRIP LOT NUMBER WAS PROVIDED BY THE CUSTOMER, RETAINED STRIPS OF LOT 365985 WERE USED FOR METER INVESTIGATIONAL PURPOSES AS IT SHARED THE SAME STRIP CODE AS THE LAST RESULTS ON THE METER MEMORY. DURING THE INVESTIGATION, IMPEDANCE CURVES WITH A WEAK SLOPE WERE OBSERVED. DISCREPANT RESULTS CAUSED BY WEAK SLOPE CHANGES ARE RELATED TO THE SOFTWARE PRESENT IN THE METER; THIS ISSUE WAS ADDRESSED IN CAPA (B)(4). ALTHOUGH DISCREPANT RESULTS WERE OBSERVED, THE TESTING SHOWS THAT THE SYSTEM IS PERFORMING WITHIN EXPECTATIONS. THE RETURNED METER PASSED FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING IN-HOUSE INVESTIGATION. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. 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. 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 (B)(4); 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; THE 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION UPDATE: IMPEDANCE CURVES ANALYSIS OF THE CUSTOMER'S RESULTS OF (B)(6) 2015 DETERMINED THAT THE CURVES EXHIBITED A NORMAL SLOPE CHANGE. THE REMAINING CUSTOMER RESULTS COULD NOT BE ANALYZED BECAUSE THE INRATIO2 SYSTEM CAN ONLY STORE UP TO 4 IMPEDANCE CURVES.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PATIENT SELF TESTER ALLEGING DISCREPANT INRATIO RESULTS. PATIENT'S THERAPEUTIC RANGE 2.5 - 3.5. (B)(6) 2015 INRATIO INR = 2.3; INRATIO INR = 2.3; INRATIO INR = 1.9; INRATIO INR = 1.9; LAB = 3.2 TESTS PERFORMED WITH AN HOUR OF EACH OTHER; INRATIO INR = 1.4; REPEAT INRATIO INR = 2.0 ONE MINUTE BETWEEN TESTS. NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570588 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432

    Patients

    Seq Age Sex Outcome Treatment
    1