BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5072112 · Received September 11, 2015

    Report

    Report Number
    2027969-2015-00667
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 20, 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
    MA, US
    Reporter Occupation
    PATIENT

    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 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. 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. DONOR TESTING WAS PERFORMED WITH THE RETURNED MONITOR AND RETAINED STRIPS BECAUSE THE CUSTOMER'S STRIPS WERE NOT RETURNED. RETAINED STRIPS OF LOT 367839A WERE DEPLETED AT THE TIME OF THE INVESTIGATION; THEREFORE, LOT 367840 WAS USED FOR TESTING OF THE RETURNED MONITOR AS THIS LOT ORIGINATED FROM THE SAME BRICK AS THE REPORTED LOT. THE SYSTEM PERFORMED AS EXPECTED DURING THE INVESTIGATION. THE RETURNED MONITOR MET FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING THE INVESTIGATION AND PERFORMED AS EXPECTED. LOT MEETS RELEASE CRITERIA. MANUFACTURING BATCH RECORD REVIEW REVEALED NO NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATIONS. A REVIEW OF IN-HOUSE TESTING HISTORY FOR STRIP LOT 367839A WAS PERFORMED AND THE LOT MET RELEASE CRITERIA. THE IMPEDANCE CURVES ASSOCIATED WITH THE CUSTOMER'S INRATIO INR RESULT OF 1.4 WAS STATISTICALLY ANALYZED AND WAS FOUND TO EXHIBIT A WEAK-SLOPE CHANGE. INTERNAL INVESTIGATION ((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, SEPSIS) CAN CONTRIBUTE TO WEAK SLOPE CHANGE IMPEDANCE CURVES. THERE ARE NO KNOWN MEDICAL CONDITIONS PROVIDED BY THE CUSTOMER THAT WOULD INTERFERE WITH THE TEST. INVESTIGATION 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. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2015, INRATIO INR: 1.4, LABORATORY INR: 2.2. THE TIME BETWEEN TESTING WAS THIRTY (30) MINUTES. THERAPEUTIC RANGE: 2.0 - 3.0. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602396 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 367839A

    Patients

    Seq Age Sex Outcome Treatment
    1