BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3063384 · Received April 11, 2013

    Report

    Report Number
    2027969-2013-00295
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IS ANEMIC AND PROVIDED HEMATOCRIT OF 26.4%. PATIENT CURRENT HEALTH STATUS MAY AFFECT COAGULATION TEST. A HEMATOCRIT THAT IS HIGHER (>55%) OR LOWER (<30%) THAN THE VALIDATED OPERATING RANGE OF INRATIO SYSTEMS CAN CAUSE AN INACCURATE RESULT OR TESTING ERRORS. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE (B)(6) 2013; INRATIO 2.8; REFERENCE 1.6; MEAN 2.2; CONFIDENCE LIMITS - 1.4 - 3.1. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES WERE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS WERE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. IN-HOUSE THERAPEUTIC DONOR TESTING WAS PERFORMED ON REPORTED LOT # 299629 ON (B)(6) 2013. RESULTS AS FOLLOWS: DONOR 212, 215; INRATIO 2.2, 2.1, 2.2, 2.5, 2.2, 2.2; REFERENCE 2.09, 2.21; BIAS THRESHOLD 1.09 - 3.09, 1.21 - 3.21; %CV 2.66, 7.53. RETENTION PRODUCTS PERFORMED AS EXPECTED. ALL REPLICATES WERE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY AND YIELDED A %CV OF LESS THAN 16%, PASSING THE PRECISION CRITERIA. NO FURTHER INVESTIGATION WAS REQUIRED. CONCLUSION: ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT WAS EXPECTED TO BE RETURNED SO RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND PRECISION CRITERIA. PATIENT WAS IDENTIFIED AS BEING ANEMIC. PATIENT'S CONDITION MAY HAVE CONTRIBUTED TO UNEXPECTED RESULTS. AS STATED IN THE PRODUCT INSERT, INRATIO HAS LIMITATION THAT HEMATOCRIT RANGES 30-55% HAVE BEEN SHOWN TO NOT AFFECT TEST RESULTS. (B)(4). THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: DATE -(B)(6) 2013; INRATIO - 2.8, LAB - 1.6. TIME BETWEEN TESTING: 2 HOURS. THERAPEUTIC RANGE: 2.0-3.0. NURSE IS USING A SAMPLE FROM A VENOUS DRAW TO PERFORM THE INRATIO2 TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154939 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 299629

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN