BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5779618 · Received July 8, 2016

    Report

    Report Number
    2027969-2016-00500
    Event Type
    Malfunction
    Date Received
    July 8, 2016
    Date of Event
    June 13, 2016
    Report Date
    June 14, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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. 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. RECALL IS INDICATED. USAGE OF DEVICE: CHANGED FROM "UNKNOWN" TO "REUSE" SINCE THE MONITOR IS NOT A SINGLE USE DEVICE. INVESTIGATION/CONCLUSION: THE MONITOR AND STRIPS ASSOCIATED WITH THE COMPLAINT WERE RETURNED FOR INVESTIGATION. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE TESTING. RETAIN AND RETURNED STRIPS TESTED ON THE RETURNED MONITOR MET ACCURACY CRITERIA. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED MONITOR WITH PASSING RESULTS. ALTHOUGH THE MONITOR FAILED THERMISTOR TESTING, FI-14-036 DETERMINED THAT THE LOWER TEMPERATURE RANGES INVESTIGATED WERE NOT FOUND TO IMPACT THE PERFORMANCE OF THE MONITOR. A REVIEW OF THE ENTIRE IN-HOUSE TESTING FOR LOT 385358A WAS PERFORMED AND FOUND THAT THE LOT MEETS CRITERIA; NO PRODUCT DEFICIENCY WAS FOUND FOR THIS LOT. MANUFACTURING BATCH RECORDS FOR THE LOT WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. ALTHOUGH THE CUSTOMER'S REPORTED INRATIO INR RESULT COULD NOT BE LOCATED IN THE MONITOR MEMORY, IMPEDANCE CURVE ANALYSIS WAS PERFORMED ON THE CUSTOMER'S LAST FOUR SAVED RESULTS IN THE MONITOR MEMORY. THREE OF THESE RESULTS, INCLUDING THE RESULT OBTAINED ON 6/13/2016, WERE FOUND TO BE EXHIBITING A WEAK-SLOPE CHANGE. CAPA INVESTIGATION ((B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES EXHIBITING A WEAK-SLOPE CHANGE OR CURVES WHICH ARE PERTURBED IN SHAPE CAN LEAD TO DISCREPANT RESULTS; THIS ISSUE IS RELATED TO THE ALGORITHM SOFTWARE ON THE MONITOR. THE CAPA INVESTIGATION HAS ALSO DETERMINED THAT CERTAIN PATIENT CONDITIONS CAN CONTRIBUTE TO WEAK-SLOPE CHANGE IMPEDANCE CURVES. THE CUSTOMER INDICATED HAVING LIVER FAILURE. THIS IS A CONDITION WHICH MAY IMPACT THE PERFORMANCE OF THE ASSAY. FI-14-036 DETERMINED THAT HEATER PLATES RUNNING SLIGHTLY BELOW SPECIFICATIONS WERE NOT FOUND TO IMPACT THE PERFORMANCE OF THE MONITOR. (B)(4) WAS INITIATED TO INVESTIGATE THE CAUSE OF HIGHLY DISCREPANT RESULTS. FURTHER INVESTIGATION INTO THIS ISSUE IS BEING PERFORMED UNDER (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    VARIANCE REPORTED BETWEEN INRATIO INR RESULT AND LAB INR RESULT. THE RESULTS WERE AS FOLLOWS: ON (B)(6) 2016 LAB INR VALUE=1.5, INRATIO INR VALUE= 2.4. WHEN TEST WAS PERFORMED, PATIENT HAD NOT BEEN ON ANTICOAGULATION THERAPY FOR 2 YEARS. HE DID NOT HAVE A THERAPEUTIC RANGE AT THE TIME OF THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434178 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 385358A

    Patients

    Seq Age Sex Outcome Treatment
    1