BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5210153 · Received November 9, 2015

    Report

    Report Number
    2027969-2015-00913
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 7, 2015
    Report Date
    October 12, 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

    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. REMOVED THE MONITOR AS A CONCOMITANT MEDICAL PRODUCT AND ADDED THE INRATIO PT/INR TEST STRIPS G5 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: CHANGE 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. DONOR TESTING WAS PERFORMED WITH THE RETURNED MONITOR AND RETAINED STRIPS OF LOT 367325. RETAINED STRIPS OF THE LOT IDENTIFIED FROM THE RETURNED MONITOR'S MEMORY HAD BEEN DEPLETED PRIOR TO THE INVESTIGATION; THEREFORE, STRIPS FROM A LOT MANUFACTURED PRIOR TO THE CUSTOMER'S LAST USED LOT WERE USED FOR THE INVESTIGATION. A STATISTICAL ANALYSIS OF THE IMPEDANCE CURVE ASSOCIATED WITH AN IN-HOUSE DISCREPANT RESULT DETERMINED THAT THE CURVE EXHIBITED A WEAK-SLOPE CHANGE. IMPEDANCE CURVES WITH WEAK SLOPE CHANGES CAN RESULT IN DISCREPANT RESULTS. THIS ISSUE IS RELATED TO THE SOFTWARE ON THE MONITOR AND WAS ADDRESSED IN (B)(4). FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED MONITOR WITH PASSING RESULTS. WITH THE EXCEPTION OF THE WEAK-SLOPE OBSERVED DURING IN-HOUSE TESTING, IN-HOUSE TESTING SHOWS THAT THE SYSTEM IS PERFORMING WITHIN EXPECTATIONS. MANUFACTURING RECORDS COULD NOT BE REVIEWED BECAUSE NO LOT NUMBER WAS PROVIDED. IMPEDANCE CURVE ANALYSIS OF THE CUSTOMER'S REPORTED RESULTS DETERMINED THAT THE CURVES EXHIBITED A NORMAL SLOPE CHANGE. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. THE CUSTOMER WAS REPORTED TO HAVE RHEUMATOID ARTHRITIS; THIS CONDITION MAY IMPACT THE PERFORMANCE OF THE ASSAY. (B)(4) IDENTIFIED IMPEDANCE CURVES WITH WEAK SLOPES AS POTENTIALLY LEADING TO DISCREPANT INR VALUES. FURTHER INVESTIGATION IS BEING PERFORMED UNDER (B)(4) FOR THIS ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    THE CALLER (PATIENT SELF TESTER) ALLEGED A VARIANCE BETWEEN INRATIO INR RESULTS AND THE LAB INR RESULTS. THE RESULTS WERE AS FOLLOWS: (B)(6) 2015: INRATIO INR=5.8 - PHYSICIAN HAD PATIENT HOLD HIS WARFARIN FOR THAT EVENING. (B)(6) 2015: LAB INR=2.5. (B)(6) 2015: INRATIO INR=4.3, LAB INR=3.3. THERAPEUTIC RANGE FOR THE PATIENT SELF TESTER: 2.5-3.5. IT WAS NOTED THAT THE PATIENT SELF TESTER WAS MILKING HIS FINGER AFTER THE FINGER STICK AND WAS NOT USING THE FIRST DROP OF BLOOD WHEN APPLYING THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742349 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432

    Patients

    Seq Age Sex Outcome Treatment
    1