BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5027424 · Received August 25, 2015

    Report

    Report Number
    2027969-2015-00617
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 3, 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
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    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 MONITOR AS ABOVE 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: THE MONITOR AND THREE (3) STRIPS ASSOCIATED WITH THE COMPLAINT WERE RETURNED FOR INVESTIGATION. THERE WERE NOT ENOUGH RETAINED STRIPS AVAILABLE FOR LOT 360632 TO COMPLETE TESTING OF THE RETURNED MONITOR, SO A SUBSTITUTE LOT WAS USED FOR INVESTIGATION. A REVIEW OF THE TESTING HISTORY FOR LOT 360632 WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT 360632 MEETS CRITERIA AND NO PRODUCT DEFICIENCY ESTABLISHED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. INVESTIGATION INTO THE RETURNED MONITOR REVEALED THAT THE HEATER PLATE THERMISTORS WERE NOT WITHIN SPECIFICATION. STATISTICAL ANALYSIS OF TESTING PERFORMED AS PART OF AN EXTENDED COMPLAINT FAILURE INVESTIGATION (REFERENCE (B)(4)) FOUND THERE TO BE NO SIGNIFICANT DIFFERENCE IN INR VALUES BETWEEN RETURNED MONITORS THAT FAILED THE HEATING SPECIFICATION WITH MONITORS THAT PASSED THE HEATING SPECIFICATION. IMPEDANCE CURVE ANALYSIS WAS NOT PERFORMED ON THE REPORTED INRATIO INR RESULTS OF 1.5 AND 3.7 AS THESE VALUES WERE NOT PRESENT IN THE MONITOR MEMORY. THE IMPEDANCE CURVE FOR THE CUSTOMER'S REPORTED INRATIO INR RESULT OF 6.4 WAS STATISTICALLY ANALYZED AND WAS CONCLUDED TO BE ABNORMAL IN SHAPE. THIS ISSUE IS RELATED TO SOFTWARE AND WAS ADDRESSED IN INTERNAL CAPA-(B)(4). CAPA-(B)(4) IDENTIFIED IMPEDANCE CURVES WITH WEAK SLOPES AND ABNORMALITIES AS POTENTIALLY LEADING TO DISCREPANT INR VALUES. THE CAPA INVESTIGATION HAS ALSO DETERMINED THAT CERTAIN PATIENT CONDITIONS CAN CONTRIBUTE TO WEAK SLOPE CHANGE IMPEDANCE CURVES. THE CUSTOMER DID NOT REPORT A MEDICAL CONDITION THAT WOULD INTERFERE WITH THE TEST. FURTHER INVESTIGATION PERFORMED UNDER CAPA-(B)(4).

    Description of Event or Problem · 1

    THE CALLER ALLEGED A VARIANCE BETWEEN THE INRATIO INR RESULT AND THE LABORATORY INR RESULT. PRIOR TO (B)(6) 2015, THE PATIENT WAS TAKING WARFARIN 7.5MG 4 DAYS A WEEK AND 5MG 3 DAYS A WEEK. ON (B)(6) 2015, THE PATIENT TESTED ON THE INRATIO DEVICE AND RECEIVED AN INR OF 1.3 WHICH WAS BELOW THE THERAPEUTIC RANGE OF 2.5 - 3.5. HIS WARFARIN WAS INCREASED TO 7.5MG DAILY. ON (B)(6) 2015, THE PATIENT'S INRATIO INR WAS 6.4. THREE (3) HOURS LATER, THE LABORATORY INR WAS 1.5. THERE WERE NO MEDICATIONS OR FOOD TAKEN BETWEEN THESE TESTS. ON (B)(6) 2015, THE PATIENT'S INRATIO INR WAS 1.5. ON (B)(6) 2015, THE PATIENT'S INRATIO INR WS 3.7 AND AN ALTERNATE POINT OF CARE (POC) INR WAS 2.8. THE PATIENT CONTINUED ON THE SAME WARFARIN DOSAGE (7.5MG DAILY). THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560032 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 360632

    Patients

    Seq Age Sex Outcome Treatment
    1