BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5234022 · Received November 18, 2015

    Report

    Report Number
    2027969-2015-00943
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 19, 2015
    Report Date
    October 22, 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
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS:BRAND NAME: REMOVED INRATIO PT/INR TEST STRIP (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 STREIP LOT NUMBER AND INCLUDED THE SERIAL NUMBER OF THE 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: ONLY THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION; NO TEST STRIPS WERE PROVIDED. THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED. RETAIN STRIP TESTING ON THE RETURNED MONITOR MEETS CRITERIA. A REVIEW OF THE ENTIRE TESTING HISTORY FOR LOT 376877A WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT 376877A MEETS RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED DURING IN-HOUSE INVESTIGATION. FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED MONITOR WITH PASSING RESULTS. THE IMPROPER TECHNIQUE IDENTIFIED IN THE COMPLAINT COULD NOT BE RULED OUT AS A POSSIBLE CAUSE OF THE UNEXPECTED RESULT. THE MANUFACTURING RECORDS FOR THE LOT 376877A WERE REVIEWED AND DID NOT UNCOVER ANY NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATION. THE IMPEDANCE CURVE FOR THE CUSTOMER'S RESULT OF 1.2 WAS STATISTICALLY ANALYZED AND WAS CONCLUDED TO HAVE A WEAK-SLOPE CHANGE. CURVES WITH WEAK SLOPE CHANGES CAN RESULT IN DISCREPANT RESULTS. THIS ISSUE IS RELATED TO THE SOFTWARE ON THE MONITOR AND WAS ADDRESSED IN CAPA-(B)(4). THE CAPA INVESTIGATION HAS ALSO DETERMINED THAT CERTAIN PATIENT CONDITIONS CAN CONTRIBUTE TO WEAK SLOPE CHANGE IMPEDANCE CURVES. THERE ARE NO KNOWN MEDICAL CONDITIONS PROVIDED BY THE CUSTOMER THAT WOULD INTERFERE WITH THE TEST. 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

    THE CALLER ALLEGED A VARIANCE BETWEEN INRATIO INR RESULT AND THE LAB INR RESULT. THE RESULTS WERE AS FOLLOWS: (B)(6) 2015 LAB INR=2.48, INRATIO INR= 1.2. THE PATIENT SELF TESTER'S THERAPEUTIC RANGE IS: 2-3. PATIENT SELF TESTER WAS MILKING HIS FINGER FOLLOWING THE FINGERSTICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763465 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 376877A

    Patients

    Seq Age Sex Outcome Treatment
    1