BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 4952512 · Received July 30, 2015

    Report

    Report Number
    2027969-2015-00549
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 14, 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
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING WAS PERFORMED. THE RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS REVEALED THAT THE LOT HAD MET RELEASE SPECIFICATIONS. A ROOT CAUSE IS UNABLE TO BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    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 MONITOR. REMOVED THE MONITOR AS A CONCOMITANT MEDICAL PRODUCT AND ADDED THE INRATIO PT/INR TEST STRIPS. G5 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 UPDATED: A REVIEW OF THE TESTING HISTORY FOR LOT 360632 WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT 360632 MEETS CRITERIA AND NO DEFICIENCIES WERE FOUND. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. THE RETURNED MONITOR MET FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING INVESTIGATION. THE IMPEDANCE CURVE ASSOCIATED WITH THE CUSTOMER'S INRATIO INR RESULT OF 3.4 WAS ANALYZED STATISTICALLY AND WAS FOUND TO EXHIBIT A WEAK-SLOPE CHANGE. CAPA INVESTIGATION (CAPA-(B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH WEAK SLOPE CHANGE CAN CAUSE DISCREPANT RESULTS. NO PATIENT CONDITIONS WERE PROVIDED BY THE CUSTOMER TO DETERMINE IF THESE LED TO THE WEAK SLOPE CHANGE OBSERVED. THERE ARE NO KNOWN MEDICAL CONDITIONS PROVIDED BY THE CUSTOMER THAT WOULD INTERFERE WITH THE TEST. FURTHER INVESTIGATION PERFORMED UNDER CAPA-(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: 3.4, LABORATORY INR: 1.6. THERAPEUTIC RANGE: 2.0 - 3.0. THE TIME BETWEEN TESTING WAS THIRTY (30) MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498881 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 360632

    Patients

    Seq Age Sex Outcome Treatment
    1