BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5151700 · Received October 15, 2015

    Report

    Report Number
    2027969-2015-00849
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 16, 2015
    Report Date
    September 17, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    THE METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED METER WITH PASSING RESULTS. RETAIN STRIP INVESTIGATION WAS NOT PERFORMED ON THE RETURNED METER. THE RECOVERED IMPEDANCE CURVE ASSOCIATED WITH THE CUSTOMER'S REPORTED INRATIO INR RESULT OF 3.7 EXHIBITS A WEAK-SLOPE CHANGE. WEAK-SLOPE CHANGES ARE KNOWN TO CONTRIBUTE TO DISCREPANT RESULTS. THIS ISSUE IS RELATED TO THE ALGORITHM SOFTWARE ON THE METER AND WAS ADDRESSED IN CAPA-(B)(4). DUE TO THIS ISSUE BEING IDENTIFIED AS THE CAUSE OF THE CUSTOMER DISCREPANT RESULT, DONOR TESTING OF THE METER WAS NOT NECESSARY. A REVIEW OF THE ENTIRE TESTING HISTORY FOR LOT K370017 WAS PERFORMED. IN-HOUSE TESTING FOR THIS LOT MEETS CRITERIA. NO PRODUCT DEFICIENCY WAS FOUND FOR LOT K370017. A REVIEW OF THE MANUFACTURING BATCH RECORDS FOR THE REPORTED STRIP LOT DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATIONS. THE IMPEDANCE CURVE FOR THE CUSTOMER'S RESULT OF 3.7 EXHIBITED A WEAK-SLOPE CHANGE. CAPA INVESTIGATION (CAPA-(B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH A WEAK-SLOPE CHANGE CAN CAUSE DISCREPANT RESULTS. THE INRATIO METER 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. NO PATIENT CONDITIONS WERE PROVIDED BY THE CUSTOMER TO DETERMINE IF THESE LED TO THE WEAK SLOPE CHANGE OBSERVED. 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. 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. 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.

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6). PRODUCT SPECIALIST ALLEGING DISCREPANT RESULTS DURING AN INRATIO TRAINING. INRATIO 3.7; REPEAT INRATIO ON ANOTHER METER (SERIAL NUMBER UNKNOWN) 1.8. PATIENT'S THERAPEUTIC RANGE UNKNOWN. NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685178 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200433 K370017

    Patients

    Seq Age Sex Outcome Treatment
    1