BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5076011 · Received September 14, 2015

    Report

    Report Number
    2027969-2015-00672
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 17, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    Z-0880,0881,0882-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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. 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 CUSTOMER'S COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE TESTING. RETAIN STRIPS TESTED ON THE RETURNED MONITOR MET ACCURACY CRITERIA. WHEN REVIEWING THE ENTIRE IN-HOUSE TESTING HISTORY FOR LOT 355822, IT WAS FOUND THAT THE LOT MEETS CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT 355822 DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. THE RETURNED MONITOR PASSED FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING IN-HOUSE INVESTIGATION. THE IMPEDANCE CURVE ASSOCIATED WITH THE CUSTOMER'S INRATIO INR RESULT OF 2.1 WAS STATISTICALLY ANALYZED AND CONCLUDED TO EXHIBIT WEAK SLOPE AND ABNORMALITY IN SHAPE. THE CURVE ASSOCIATED WITH THE CUSTOMER'S RESULT OF 2.3 WAS ALSO DETERMINED TO EXHIBIT WEAK SLOPE. CAPA INVESTIGATION (B)(4) HAS DETERMINED THAT IMPEDANCE CURVES WITH WEAK SLOPE CHANGE CAN CAUSE DISCREPANT RESULTS. THE INRATIO MONITOR SOFTWARE MAY GENERATE AN INCORRECT OR DISCREPANT INR RESULT WHEN THE PATIENT SAMPLE EXHIBITS A WEAK-SLOPE CHANGE IMPEDANCE CURVE. THE CAPA INVESTIGATION HAS ALSO DETERMINED THAT CERTAIN PATIENT CONDITIONS CAN CONTRIBUTE TO WEAK SLOPE CHANGE IMPEDANCE CURVES. THE CONDITIONS PROVIDED BY THE CUSTOMER WERE NOT FOUND TO BE ASSOCIATED WITH WEAK SLOPE CHANGE IMPEDANCE CURVES. CAPA (B)(4) IDENTIFIED IMPEDANCE CURVES WITH WEAK SLOPES AS POTENTIALLY LEADING TO DISCREPANT INR VALUES. FURTHER INVESTIGATION IS BEING PERFORMED UNDER CAPA (B)(4) FOR THIS ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PATIENT SELF TESTER'S DAUGHTER, (B)(6) (AN RN) REPORTED A DISCREPANT LOW INRATIO RESULT VS. THE LAB INR. THE RESULTS ARE AS FOLLOWS: (B)(6) LAB=6.8; INRATIO=2.3, REPEAT=2.1. PATIENT SELF TESTER'S THERAPEUTIC RANGE IS: 2.0-3.0. PATIENT SELF TESTER'S DAUGHTER STATED THAT VITAMIN K WAS PRESCRIBED BASED ON THE LAB RESULT AND WAS ADMINISTERED AFTER THE INRATIO TEST WAS PERFORMED. ADDITIONAL RESULTS PROVIDED BY THE DISTRIBUTOR AT THE REQUEST OF TECHNICAL SERVICE REP. (B)(6) INRATIO=2.0, (B)(6) INRATIO=2.1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605080 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 355822

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention