BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 4960191 · Received August 3, 2015

    Report

    Report Number
    2027969-2015-00556
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 9, 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
    GM
    Reporter Occupation
    OTHER

    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 MODEL36V20431 LOT#: REMOVED INRATIO PT/INR TEST STRIP LOT NUMBER AND INCLUDED SERIAL NUMBER OF MONITOR. 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 WAS RETURNED FOR INVESTIGATION, HOWEVER NO TESTING STRIPS WERE RETURNED. IMPEDANCE CURVE ANALYSIS COULD NOT BE PERFORMED ON THE CUSTOMER'S REPORTED INRATIO INR RESULTS FOR ANY OF THE PATIENTS BECAUSE ONLY THE LAST FOUR (4) IMPEDANCE CURVES CAN BE RETRIEVED FROM THE MONITOR MEMORY. THE CUSTOMER'S RESULTS WERE NOT FOUND WITHIN THE LAST FOUR (4) IMPEDANCE CURVES. THE RETURNED MONITOR PASSED FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING IN-HOUSE INVESTIGATION. SINCE THE CUSTOMER'S STRIPS WERE NOT RETURNED FOR INVESTIGATION, THERAPEUTIC DONOR TESTING WAS PERFORMED USING THE RETURNED MONITOR AND RETAINED STRIPS FOR LOT K366399. DURING IN-HOUSE INVESTIGATION, AN IMPEDANCE CURVE WITH A WEAK SLOPE CHANGE WAS OBSERVED WITH ONE OF THE DONOR RESULTS. DISCREPANT RESULTS CAUSED BY WEAK SLOPE CHANGES ARE RELATED TO THE SOFTWARE ON THE MONITOR; THIS ISSUE WAS ADDRESSED IN INTERNAL CAPA-(B)(4). ALTHOUGH DISCREPANT RESULTS WERE OBSERVED DURING IN-HOUSE TESTING, AN ANALYSIS OF ALL IN-HOUSE TESTING RESULTS FOR LOT K366399 DETERMINED THAT THE STRIP LOT MET EXPECTATIONS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. SEVERAL REPORTED INRATIO INR RESULTS CAME FROM PATIENTS THAT HAD STOPPED ANTICOAGULANT THERAPY FOR A PERIOD OF TIME WHEN THE TESTS WERE PERFORMED. THE INRATIO SYSTEM IS DESIGNED FOR PATIENTS TAKING WARFARIN AND OTHER ANTICOAGULANT THERAPY.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN GERMANY. THE PHYSICIAN'S OFFICE PREVIOUSLY REPORTED ALLEGED VARIANCE IN RESULTS THAT HAD OCCURRED IN THE PAST BUT NONE OF THE RESULTS WERE DOCUMENTED. ALERE RECOMMENDED PERFORMING COMPARATIVE MEASUREMENTS. THE OFFICE REPORTED A VARIANCE BETWEEN THE INRATIO2 INR, ALTERNATE POINT OF CARE (POC) INR AND THE LABORATORY INR. RESULTS ARE AS FOLLOWS: PATIENT 7: INRATIO2 INR: 2.6, POC INR: 1.0, LAB INR: 0.94. THE PATIENT WAS NOT TAKING PHENPROCOUMON DUE TO AN UPCOMING OPERATION. THE THERAPEUTIC RANGE WAS NOT PROVIDED. THERE WAS NO REPORTED ADVERSE PATIENT SEQULA.

    Description of Event or Problem · 1

    THE PHYSICIAN'S OFFICE IN (B)(6) REPORTED VARIANCES BETWEEN THE INRATIO2 INR RESULTS, AN ALTERNATE POINT OF CARE (POC) INR RESULTS AND THE LABORATORY INR RESULTS ON A TOTAL OF 13 PATIENT'S. ELEVEN (11) OF THE PATIENT'S WERE NOT TAKING PHENPROCOUMON AT THE TIME OF TESTING. RESULTS ARE AS FOLLOWS: (B)(6). THERAPEUTIC RANGE NOT PROVIDED. THE SAME INRATIO2 MONITOR AND TESTING STRIP LOT WAS USED FOR ALL THE PATIENTS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505817 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 36V20431 K366399

    Patients

    Seq Age Sex Outcome Treatment
    1