BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3281973 · Received August 6, 2013

    Report

    Report Number
    2027969-2013-00674
    Event Type
    Malfunction
    Date Received
    August 6, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 18, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DATA ANALYSIS PERFORMED ON INR RESULTS PROVIDED BY CUSTOMER. THERAPEUTIC DONOR TESTING WITH RETURNED METER SN: (B)(4) AND RETAIN STRIPS LN: 312528. FUNCTIONAL TESTING ON INRATIO METER SN: (B)(4). ANALYSIS OF REPORTED DATA: DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2013, INRATIO METER: 5.1, REFERENCE: 1.7, MEAN: 3.4, CONFIDENCE LIMITS: 2.0-5.0. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED, BOTH INRATIO INR AND THE REFERENCE VALUE WERE OUTSIDE OF THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS WERE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. FURTHER INVESTIGATION WAS REQUIRED. INVESTIGATION DETAILS: A STRIP INVESTIGATION WAS PERFORMED ON LOT 312528. ALL REPLICATES FOR BOTH SAMPLES FOR STRIP LOT 312528 ARE WITHIN THE ALLOWABLE BIAS. THIS PASSES ACCURACY CRITERIA. NO FURTHER ACTION IS REQUIRED. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT 3122528, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. ALL SAMPLES MET THE CRITERIA FOR PRECISION, (%CV WAS LESS THAN 16.0%). NO FURTHER ACTION IS REQUIRED. FUNCTIONAL TESTING: FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED METER WITH PASSING RESULTS. METER INVESTIGATION (INSPECTION): UNIT WAS THEN TESTED WITH THERMOMETER SENSING TEST DURING WARMING UP TO DETERMINE IF UNIT'S HEATER PLATE IS WITHIN THE STANDARD SPECIFICATION (36.00-38.00 DEGREE C). PERFORMED THERMOMETER SENSING TEST ON UNIT AND BOTH THERMISTOR ARE MEASURED AS FOLLOWS: THERMISTOR A = 36.39 DEGREES C THERMISTOR B = 36.7 DEGREES C. VISUAL INSPECTION REVEALED NO SIGNIFICANT CONTAMINATION ON HEATER PLATE. METER MEMORY: METER MEMORY WAS REVIEWED. THE INR RESULT OF 5.1 WAS PRESENT IN THE METER MEMORY ON (B)(6) 2013 AND NOT ON THE REPORTED DATE OF OCCURRENCE ON (B)(6) 2013. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT THE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. NO PRODUCT WAS RETURNED SO RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. RETAIN STRIP TESTING RESULTS MET ACCURACY AND PRECISION CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. (B)(4) DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #312528, YIELDING A COMPLAINT RATE OF (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION; NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013, INRATIO INR: 5.1, LABORATORY INR: 1.7. THE TIME BETWEEN TESTING WAS WITHIN MINUTES. THERAPEUTIC RANGE IS 2.0 - 3.0 FOR THE PATIENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369526 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 312528

    Patients

    Seq Age Sex Outcome Treatment
    1 Other COUMADIN| UNSPECIFIED PAIN MEDICATION