BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 4945940 · Received July 28, 2015

    Report

    Report Number
    2027969-2015-00539
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    July 7, 2015
    Report Date
    July 7, 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
    ID, US
    Reporter Occupation
    PATIENT

    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 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. THE STRIPS ASSOCIATED WITH THE COMPLAINT WERE NOT RETURNED FOR INVESTIGATION. ADDITIONALLY, THERE WERE NOT ENOUGH RETAINED STRIPS AVAILABLE FOR THE REPORTED STRIP LOT, 360632, AT THE TIME OF TESTING. LOT NUMBER 364995A WAS SELECTED FOR INVESTIGATION PURPOSES TO TEST THE PERFORMANCE OF THE MONITOR. DISCREPANT RESULTS OUTSIDE OF THE ACCEPTABLE RANGE WERE OBSERVED DURING IN-HOUSE TESTING OF THE RETURNED MONITOR AND THE CUSTOMER'S COMPLAINT OF A DISCREPANT LOW RESULT WAS REPLICATED. A STATISTICAL ANALYSIS OF AN IMPEDANCE CURVE GENERATED DURING IN-HOUSE TESTING FOUND THAT A DISCREPANT RESULT WAS CAUSED BY A WEAK-SLOPE CHANGE. THIS ISSUE IS RELATED TO SOFTWARE AND WAS ADDRESSED IN INTERNAL CAPA-(B)(4). ALTHOUGH DISCREPANCIES WERE OBSERVED DURING IN-HOUSE TESTING, IN-HOUSE TESTING SHOWS THAT THE SYSTEM IS PERFORMING WITHIN EXPECTATIONS. FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED MONITOR WITH PASSING RESULTS. A REVIEW OF THE TESTING HISTORY FOR 360632 WAS PERFORMED AND MET CRITERIA WITH NO PRODUCT DEFICIENCY FOUND. THE MANUFACTURING RECORDS FOR LOT 360632 WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. THE IMPEDANCE CURVE FOR THE CUSTOMER'S RESULT OF 1.2 WAS STATISTICALLY ANALYZED AND WAS CONCLUDED TO BE NORMAL IN SHAPE. THE IMPEDANCE CURVE ANALYSIS WAS NOT PERFORMED ON THE RESULT OF 1.7 BECAUSE THE VALUE WAS NOT PRESENT IN THE MONITOR MEMORY. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. CAPA-(B)(4) IDENTIFIED IMPEDANCE CURVES WITH WEAK SLOPES AS POTENTIALLY LEADING TO DISCREPANT INR VALUES. FURTHER INVESTIGATION WAS PERFORMED UNDER CAPA-(B)(4) FOR THIS ISSUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED AS (B)(6) 2015 SINCE THIS WAS THE DATE THE CUSTOMER CALLED TO REPORT THE EVENT. THE CUSTOMER WAS NOT ABLE TO PROVIDE THE DATES OF OCCURRENCE. INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    THE CALLER ALLEGED A VARIANCE BETWEEN THE INRATIO INR RESULTS AND THE LABORATORY INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: UNKNOWN INRATIO INR: 1.2 LABORATORY INR: 2.3; UNKNOWN DATE BUT THE FOLLOWING WEEK AFTER ABOVE RESULTS, 1.7, 2.5. THERAPEUTIC RANGE: 2.4 - 3.4. THE TIME BETWEEN TESTING ON EACH DATE WAS WITHIN ONE (1) HOUR. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491109 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 360632

    Patients

    Seq Age Sex Outcome Treatment
    1