BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5168282 · Received October 22, 2015

    Report

    Report Number
    2027969-2015-00872
    Event Type
    Malfunction
    Date Received
    October 22, 2015
    Date of Event
    September 24, 2015
    Report Date
    September 25, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. SINCE THE CUSTOMER'S STRIPS WERE NOT RETURNED, RETAINED STRIPS WERE USED TO TEST THE RETURNED METER. RETAINED STRIPS OF THE REPORTED LOT WERE DEPLETED PRIOR TO THE INVESTIGATION. THEREFORE, RETAINED LOT 365430 WAS USED AS IT ORIGINATED FROM THE SAME BRICK AS THE CUSTOMER'S REPORTED LOT. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE TESTING. RETAINED STRIPS TESTED ON THE RETURNED METER MET ACCURACY CRITERIA. THE SYSTEM PERFORMED AS EXPECTED. THE RETURNED METER MET FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING THE INVESTIGATION. THE RETURNED METER PERFORMED AS EXPECTED. A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY FOR STRIP LOT 365429A WAS CONDUCTED. IN-HOUSE TESTING ON THE REPORTED STRIP LOT MEETS RELEASE CRITERIA. MANUFACTURING BATCH RECORD REVIEW REVEALED NO NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATIONS. A STATISTICAL ANALYSIS OF THE IMPEDANCE CURVES ASSOCIATED WITH THE CUSTOMER'S DISCREPANT RESULTS DETERMINED THAT THE CURVES EXHIBITED NORMAL SLOPE CHANGE. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CORRECTIONS: BRAND NAME: REMOVED INRATIO PT/INR TEST STRIPS (AS THE COMPLAINT DEVICE) AND ADDED THE INRATIO2 PT MONITORING SYSTEM (MONITOR). 4 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 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PATIENT SELF TESTER ALLEGING DISCREPANT INRATIO VALUES. PATIENT'S THERAPEUTIC RANGE 2 - 3. THE FOLLOWING IS THE ORDER THE TESTS WERE PERFORMED. (B)(6) 2015: INRATIO = 7.5; REPEAT INRATIO = 5.6; 2ND REPEAT INRATIO = 2.3; LAB INR = 2.8; REPEAT INRATIO = 3.1. ALL TESTS WERE PERFORMED WITHIN THREE HOURS ON THE SAME DAY. PATIENT SELF TESTER USED THE SAME FINGER FOR ALL OF THE INRATIO TESTS. NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698980 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 365429A

    Patients

    Seq Age Sex Outcome Treatment
    1