BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 4521634 · Received February 17, 2015

    Report

    Report Number
    2027969-2015-00113
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Date of Event
    January 13, 2015
    Report Date
    January 19, 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

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    PLEASE MAKE THE FOLLOWING CORRECTIONS: (RETURNED TO MANUFACTURER ON DATE) TO READ: 01/26/2015. CORRECT TO READ: INRATIO2 MONITOR. CORRECT TO READ: MODEL #200432. DELETE LOT #355822. DELETE INRATIO MONITOR SERIAL #(B)(4). CORRECT (510(K) #) TO READ: K072727. INVESTIGATION: THE PRODUCTS WERE RETURNED FOR INVESTIGATION. THE CUSTOMER'S COMPLAINT OF DISCREPANT LOW RESULTS WAS NOT CONFIRMED DURING IN-HOUSE TESTING. RETAIN AND RETURNED STRIP TESTING ON THE RETURNED METER MET BOTH ACCURACY AND STRIP REPEATABILITY CRITERIA. THE IMPEDANCE CURVE FOR THE INRATIO INR RESULT OF 2.8 WAS ANALYZED. THE WEAK-SLOPE CHANGE IN THE CURVE MADE IT DIFFICULT FOR THE METER TO DETERMINE AN INFLECTION POINT. THIS MAY HAVE CAUSED THE METER TO DETERMINE THE PT POINT EARLIER THAN IT SHOULD HAVE. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATION. CAPA INVESTIGATION (CAPA-(B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH WEAK SLOPE CHANGE CAN CAUSE DISCREPANT RESULTS. THE CAPA INVESTIGATION HAS ALSO DETERMINED THAT CERTAIN PATIENT CONDITIONS (E.G. LOW HEMATOCRIT, ELEVATED PLASMA PROTEINS) CAN CONTRIBUTE TO WEAK SLOPE CHANGE IMPEDANCE CURVES. THE CUSTOMER WAS REPORTED TO HAVE LUPUS. A NOTIFICATION LETTER HAS BEEN SENT TO CUSTOMERS TO INFORM THEM OF THESE PATIENT CONDITIONS. BECAUSE THE PATIENT WAS REPORTED TO HAVE LUPUS, THE PATIENT'S SAMPLE MAY HAVE INTERFERED WITH THE TEST AND CANNOT BE RULED OUT AS A POSSIBLE ROOT CAUSE FOR THE UNEXPECTED RESULTS. FURTHER INVESTIGATION WILL BE CONTINUED UNDER CAPA-(B)(4).

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: DATE: 11/13; INRATIO: 3.2; LAB: 10.0; ALT POC: -; TIME BETWEEN TESTS: 1 HOUR. DATE: 1/16; INRATIO: 2.8; LAB: 8.2; ALT POC: - ; TIME BETWEEN TESTS: 1 HOUR. DATE: 1/19; INRATIO: 2.8; LAB: -; ALT POC: 8.0; TIME BETWEEN TESTS: 5 MINUTES. THERAPEUTIC RANGE: 2.0-3.2. CALLER REPORTS THAT THEIR FINGER MAY HAVE TOUCHED THE TEST STRIP BUT THEY WERE NOT SURE. PATIENT SELF TESTER WAS TO VISIT THE HOSPITAL ON 1/19 AFTER CALLING TECHNICAL SERVICES, PER PHYSICIAN'S ADVISORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113959 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 355822

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO PT/INR TEST STRIPS| MEDS:COUMADIN 5 OR 6MG/DAY, CODEINE STARTED| STRIP LOT #355822| INRATIO MONITOR SERIAL #(B)(4)| PREDNISONE