BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 4993584 · Received August 11, 2015

    Report

    Report Number
    2027969-2015-00580
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 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
    PATIENT

    Narratives

    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 THE MONITOR AS ABOVE. REMOVED THE MONITOR AS A CONCOMITANT MEDICAL PRODUCT AND ADDED THE INRATIO PT/INR TEST STRIPS FOR 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 METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION; NO TEST STRIPS WERE PROVIDED. RETAINED STRIPS FROM THE COMPLAINT LOT WERE NO LONGER AVAILABLE TO COMPLETE TESTING OF THE RETURNED METER, SO A SUBSTITUTE LOT WAS USED FOR INVESTIGATION. THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED. RETAINED STRIPS TESTED ON THE RETURNED METER MEETS ACCURACY CRITERIA. FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED METER WITH PASSING RESULTS. IN-HOUSE TESTING SHOWS THAT THE SYSTEM IS PERFORMING WITHIN EXPECTATIONS. A REVIEW OF THE ENTIRE TESTING HISTORY FOR LOT 365429A WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT 365429A MEETS CRITERIA. THE MANUFACTURING RECORDS FOR THE LOT 365429A WERE REVIEWED AND DID NOT UNCOVER ANY NON-CONFORMANCES. LOT MEETS RELEASE SPECIFICATION. THE IMPEDANCE CURVE FOR THE CUSTOMER'S RESULT OF 3.8 WAS STATISTICALLY ANALYZED AND WAS FOUND TO EXHIBIT A WEAK-SLOPE CHANGE. THE IMPEDANCE CURVE FOR THE CUSTOMER'S RESULT OF 2.0 WAS STATISTICALLY ANALYZED AND WAS FOUND TO EXHIBIT A WEAK AND ABNORMAL SLOPE CHANGE. CAPA INVESTIGATION (CAPA-(B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH WEAK AND ABNORMAL 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. THE CUSTOMER DID NOT REPORT TO HAVE A MEDICAL CONDITION THAT WOULD INTERFERE WITH THE TEST. FURTHER INVESTIGATION INTO IMPEDANCE CURVES WITH ABNORMAL AND WEAK-SLOPE CHANGES ARE BEING PERFORMED UNDER CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    THE CALLER ALLEGED A VARIANCE BETWEEN THE INRATIO INR RESULTS IN COMPARISON TO THE LAB INR RESULT. THE RESULTS WERE AS FOLLOWS: (B)(6). PATIENT SELF TESTER'S THERAPEUTIC RANGE=2.0-3.0. DOCTOR ADVISED THE PATIENT TO STOP MEDICATION FOR 3 DAYS AND WILL RE-EVALUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525124 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 365429A

    Patients

    Seq Age Sex Outcome Treatment
    1