BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5710671 · Received June 9, 2016

    Report

    Report Number
    2027969-2016-00432
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Date of Event
    March 5, 2016
    Report Date
    May 11, 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
    CA, 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. USAGE OF DEVICE: CHANGED FROM "UNKNOWN" TO "REUSE" SINCE THE MONITOR IS NOT A SINGLE USE DEVICE. INVESTIGATION/CONCLUSION: IMPEDANCE CURVE ANALYSIS FOR THE CUSTOMER'S REPORTED INRATIO INR RESULT OF 1.8 COULD NOT BE PERFORMED BECAUSE IT WAS NOT FOUND IN THE MONITOR MEMORY. THE IMPEDANCE CURVES ASSOCIATED WITH THE CUSTOMER'S INRATIO INR RESULTS OF 1.6 AND 1.9 WERE DETERMINED TO BE NORMAL IN SHAPE. THE IMPEDANCE CURVE ASSOCIATED WITH THE CUSTOMER'S INRATIO INR RESULT OF 2.2 WAS DETERMINED 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. IMPEDANCE CURVE ANALYSIS FOR THE REMAINING SEVEN RESULTS COULD NOT BE PERFORMED BECAUSE THE INRATIO 2 MONITOR ONLY STORES THE IMPEDANCE CURVES FOR THE LAST FOUR RESULTS. UNABLE TO DETERMINE A ROOT CAUSE FROM THE AVAILABLE INFORMATION. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE TESTING. RETAIN STRIPS TESTED ON THE RETURNED MONITOR MET ACCURACY CRITERIA. FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED MONITOR WITH PASSING RESULTS. A REVIEW OF THE ENTIRE IN-HOUSE TESTING FOR LOT 384085A WAS PERFORMED AND FOUND THAT THE LOT MEETS CRITERIA; NO PRODUCT DEFICIENCY WAS FOUND FOR THIS LOT. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT WAS PERFORMED; RELEASE SPECIFICATIONS WERE MET. IMPEDANCE CURVE ANALYSIS COULD NOT BE PERFORMED BECAUSE THE CUSTOMER'S REPORTED INRATIO INR RESULT WAS NOT PRESENT IN THE MONITOR MEMORY. UNABLE TO DETERMINE A ROOT CAUSE FROM THE AVAILABLE INFORMATION. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    A CALLER REPORTED A VARIANCE BETWEEN INRATIO INR RESULT AND LAB INR RESULT. THE RESULTS WERE AS FOLLOWS: (B)(6) 2016: INRATIO INR=1.8; LAB INR=3.4 REPORTED THERAPEUTIC RANGE: 2-3. ADDITIONAL RESULTS WERE ALSO PROVIDED BY THE DISTRIBUTOR SINCE THE CALLER WAS CONCERNED ABOUT DISCREPANT LOW RESULTS SINCE (B)(6) 2016. IT WAS ALSO REPORTED THAT WARFARIN DOSE IS REGULARLY CHANGED BASED ON THE INRATIO INR RESULTS IN ORDER TO KEEP THE INR WITHIN THE THERAPEUTIC RANGE. NO FURTHER INFORMATION WAS PROVIDED AS TO WHETHER THE PHYSICIAN PRESCRIBES EACH DOSE CHANGE OR PATIENT MAKES THAT DECISION. NO EXACT DATES OR INFORMATION ON DOSE CHANGES PROVIDED. HISTORICAL RESULTS PROVIDED BY THE DISTRIBUTOR: (B)(6). NO INFORMATION TO INDICATE WHICH RESULTS WERE DONE WITH THE LOT LISTED IN THIS COMPLAINT OR ALTERNATE LOT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362555 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 384085A

    Patients

    Seq Age Sex Outcome Treatment
    1