BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5394186 · Received January 27, 2016

    Report

    Report Number
    2027969-2016-00052
    Event Type
    Malfunction
    Date Received
    January 27, 2016
    Date of Event
    January 4, 2016
    Report Date
    January 6, 2016
    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
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS: THERAPEUTIC RANGE SHOULD BE 2.5 - 5.0. 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. 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. INVESTIGATION/CONCLUSION: THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION; HOWEVER, NOT TESTING STRIPS WERE RETURNED. THE DATE ON THE CUSTOMER'S RETURNED MONITOR APPEARED TO HAVE BEEN IMPROPERLY SET. THE CUSTOMER REPORTED AN INRATIO INR RESULT OF 1.5 ON (B)(6) 2016 WITH STRIP LOT 373678A (STRIP CODE BA47X). THERE WERE TWO INRATIO INR VALUES OF 1.5 IN THE MONITOR MEMORY ASSOCIATED WITH STRIP CODE BA47X. HOWEVER, BECAUSE THE LAST INRATIO INR VALUE WAS 1.5, THIS WAS USED AS THE CUSTOMER'S REPORTED RESULT FOR IMPEDANCE CURVE ANALYSIS. THE RECOVERED IMPEDANCE CURVE ASSOCIATED WITH THE CUSTOMER'S REPORTED INRATIO INR RESULT EXHIBITED A WEAK-SLOPE CHANGE. WEAK-SLOPE CHANGES ARE KNOWN TO CONTRIBUTE TO DISCREPANT RESULTS. THIS ISSUE IS RELATED TO THE ALGORITHM SOFTWARE ON THE MONITOR AND WAS ADDRESSED IN INTERNAL CAPA-(B)(4). DONOR/TETAIN STRIP TESTING OF THE MONITOR WAS NOT NECESSARY DUE TO WEAK SLOPE CHANGES IDENTIFIED AS THE CAUSE OF CUSTOMER DISCREPANT RESULTS. FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED MONITOR WITH PASSING RESULTS. A REVIEW OF THE TESTING HISTORY FOR LOT 373678A WAS PERFORMED. IN-HOUSE TESTING FOR THIS LOT MET RELEASE SPECIFICATIONS AND NO PRODUCT DEFICIENCY WAS ESTABLISHED FOR LOT 373678A. FURTHER INVESTIGATION PERFORMED UNDER CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    THE PATIENT'S (END USER'S) THERAPEUTIC RANGE WAS 2.5 - 5.0.

    Description of Event or Problem · 1

    THE CALLER (END USER) ALLEGED A VARIANCE BETWEEN THE INRATIO INR RESULT AND THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE (B)(6) 2016 INRATIO INR 1.5 LABORATORY INR 2.7 THERAPEUTIC RANGE: 2.5 - 3.5 THE TIME BETWEEN TESTING WAS FOUR (4) HOURS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52945 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 373678A

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR