BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 4642495 · Received March 30, 2015

    Report

    Report Number
    2027969-2015-00235
    Event Type
    Malfunction
    Date Received
    March 30, 2015
    Date of Event
    February 3, 2015
    Report Date
    March 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
    TX, 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. 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; HOWEVER, NO TESTING STRIPS WERE RETURNED. THE CUSTOMER'S COMPLAINT OF DISCREPANT LOW RESULTS WAS NOT CONFIRMED DURING IN-HOUSE TESTING. SINCE THE CUSTOMER DID NOT PROVIDE A LOT NUMBER, THE RETURNED MONITOR'S MEMORY WAS REVIEWED TO RETRIEVE THE STRIP CODE THAT THE CUSTOMER ENTERED INTO THE MONITOR PRIOR TO TESTING. THE INRATIO RESULT OF 1.2 WAS NOT FOUND ON (B)(6) 2015 HOWEVER, THERE WAS A 1.2 RESULT ON (B)(6) 2015 IN THE MEMORY. THE STRIP CODE WAS USED TO IDENTIFY POSSIBLE STRIP LOTS THAT WERE USED (339256); HOWEVER, RETAINS FOR THIS LOT WERE EXPENDED DURING PREVIOUS IN-HOUSE INVESTIGATIONS. NO OTHER STRIP LOT WITH PART NUMBER: 100071 WAS MANUFACTURED AT THE SAME TIME AS STRIP LOT 339256. THEREFORE, RETAIN STRIPS FROM LOT 340805 WERE CHOSEN TO EVALUATE THE PERFORMANCE OF THE RETURNED MONITOR DUE OF ITS IDENTICAL PART NUMBER ITS MANUFACTURED DATE IS NEAR TO THAT OF STRIP LOT 339256. THE RETAIN STRIP TESTING ON THE RETURNED MONITOR MET BOTH ACCURACY AND STRIP REPEATABILITY CRITERIA. THE RETURNED MONITOR MET FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING INVESTIGATION. AN IMPROPER TECHNIQUE WAS IDENTIFIED IN THE COMPLAINT, AND CANNOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULT. A REVIEW OF THE MANUFACTURING RECORDS FOR BOTH LOTS 340805 AND 339256 DID NOT UNCOVER ANY NON-CONFORMANCES AND THE LOTS MET RELEASE SPECIFICATION. THE IMPEDANCE CURVE ASSOCIATED WITH THE CUSTOMER'S RESULT WAS STATISTICALLY ANALYZED AND DID NOT EXHIBIT WEAK SLOPE CHANGE, BUT WAS ABNORMAL IN SHAPE. CAPA-(B)(4) WAS OPENED TO INVESTIGATE THE CAUSE OF HIGHLY DISCREPANT RESULTS. THE INVESTIGATION HAS DETERMINED THAT ABNORMAL CURVES MAY CAUSE THE INRATIO METER SOFTWARE TO GENERATE AN INCORRECT OR DISCREPANT INR RESULT. FURTHER INVESTIGATION IS DOCUMENTED IN CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    THE CALLER ALLEGED A DISCREPANT LOW INRATIO INR RESULT IN COMPARISON TO AN UNSPECIFIED POINT OF CARE (POC) INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2015, INRATIO INR: 1.2, POC INR: NA. (B)(6) /2015, INRATION INR: N/A, POC INR: 2.5. THERAPEUTIC RANGE: 2.0 - 3.0. THE TIME BETWEEN TESTING WAS TWENTY-FOUR (24) HOURS. THE CALLER REPORTED PERFORMING AN IMPROPER TECHNIQUE BY "MILKING" THE FINGER AFTER THE FINGER STICK. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209221 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432

    Patients

    Seq Age Sex Outcome Treatment
    1 WARFARIN| INRATIO PT/INR TEST STRIPS 100071, LOT# UNKNOWN| INRATIO MONITOR SN (B)(4)