BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 2755517 · Received September 19, 2012

    Report

    Report Number
    2027969-2012-01348
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    June 14, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS {ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: 3.2, 3.8, 3.0, 3.2 AND 2.4 INR ARE EXCLUDED FROM COMPARISON TEST. SINCE TIME OF TEST EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES OF TEST 2 FALL OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. PERFORMED REFERENCE TEST ON REPORTED LOT 1274161. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 274161 ON (B)(6) 2012. RESULTS AS FOLLOWS: DONOR A) 200, INRATIO: 2.4, 2.4, 2.4; REF: 2.10, BIAS THRESHOLD: 1.10 - 3.10; %CV: 0. DONOR B) 201; 3.3, 3.5, 3.4; 2.89; 1.89 - 3.89; 2.94. ALL REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN 16%. ACCURACY AND PRECISION CRITERIA HAVE BEEN MET. NO FURTHER TESTING IS NECESSARY. CONCLUSION: ANALYSIS OF CLIENT'S DATA FROM INRATIO AND REFERENCE METHOD REVEALED THAT TEST RESULTS ON (B)(6) 2012 DID NOT MEET ACCURACY CRITERIA. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. NO PRODUCT WAS EXPECTED TO BE RETURNED. REVIEW OF RECENT IN-HOUSE THERAPEUTIC SAMPLE TESTING FOUND RETAIN STRIPS MET ACCURACY AND PRECISION CRITERIA. AS REVIEWED ON (B)(6) 2012, 62 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #274161 YIELDING A COMPLAINT RATE OF 0.1615%. ACTION THRESHOLD (>0.07%) HAS BEEN REACHED. STRIP LOT IN COMPLAINT HAS STRIP CODE 3W084 WHICH BRICK LOT NUMBER 257218 WAS ASSIGNED AND PACKAGED INTO STRIP LOTS 274161, 274163 274164, 274165, 274167, 274166 AND 274162; 196 TOTAL DISCREPANT COMPLAINTS HAVE BEEN REPORTED FOR LOT NUMBERS 274161, 274163, 274164, 274165, 274167, 274166 AND 274162 YIELDING A COMPLAINT RATE OF 0.036%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE TOTAL COMPLAINT ACTION THRESHOLD OF 0.07%, NO FURTHER ACTION IS NECESSARY. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. SEE SCANNED TABLE.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS. PATIENT HAD SURGERY ON (B)(6) 2012. PATIENT WAS TREATED WITH CLEXANE IN THE HOSPITAL BUT SWITCHED TO WARFARIN THE DAY BEFORE HER RELEASE. PREVIOUS INR BLOOD TEST RESULTS SINCE PATIENT LEFT THE HOSPITAL. SEE SCANNED TABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO HS0100071 274161

    Patients

    Seq Age Sex Outcome Treatment
    1