BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3214788 · Received July 2, 2013

    Report

    Report Number
    2027969-2013-00534
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER APPLIED MULTIPLE DROPS OF BLOOD DURING SAMPLE APPLICATION. ONCE THE BLOOD IS ADDED TO THE SAMPLE WELL, IT WILL TRAVEL DOWN THE STRIP CHANNELS AND WILL INITIATE TESTING. ADDING MULTIPLE DROPS OF BLOOD WILL DISRUPT THE INITIAL TESTING REACTION AND MAY CONTRIBUTE TO UNEXPECTED INR RESULTS. ADDITIONALLY, THE CUSTOMER REPORTED HAVING A THYROID DISORDER AND IS TAKING LEVOTHYROXINE. BE ADVISED THAT CERTAIN DISEASES AND CONDITIONS CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS AND THE INR VALUE. THE PATIENT'S CURRENT HEALTH STATUS AND MEDICATION CANNOT BE RULED OUT AS A POSSIBLE ROOT CAUSE FOR THE REPORTED LOW INR RESULT. 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 = 1.6, REFERENCE = 3.1, MEAN = 2.35, 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 #K303866 ON (B)(4) 2013. RESULTS AS FOLLOWS: DONOR: A) (B)(6), INRATIO: 3.5, INRATIO: 3.4, INRATIO: 3.5, REFERENCE: 4.50, BIAS THRESHOLD: 3.50 - 5.50. %CV: 1.67. DONOR: B) (B)(6), INRATIO: 2.0, INRATIO: 2.0, INRATIO: 2.0, REFERENCE: 1.93, BIAS THRESHOLD: 1.43 - 2.43, %CV: 0.00. TWO OUT OF THREE REPLICATES THAT WERE TESTED FOR DONOR (B)(6) MET THE CRITERIAL FOR ACCURACY. DONOR (B)(6) WAS TESTED WITH NINE OTHER LOTS ON THE SAME DAY WITH SIMILAR RESULTS. THIS MAY HAVE INDICATED A PATIENT SPECIFIC INTERFERENCE. TO RULE OUT THE POSSIBILITY THAT THIS WAS RELATED TO PATIENT SAMPLE INTERFERENCE, TWO MORE THERAPEUTIC DONORS WERE TESTED TO ELIMINATE THE POSSIBILITY THAT THE FAILURE WAS DONOR SPECIFIC. IN-HOUSE THERAPEUTIC DONOR TESTING WAS PERFORMED ON REPORTED LOT #K303866 ON (B)(4) 2013. RESULTS AS FOLLOWS: DONOR: A) (B)(6), INRATIO: 2.7, INRATIO: 3.0, INRATIO: 2.8, REFERENCE: 3.28, BIAS THRESHOLD: 2.28-4.28. %CV: 5.39. DONOR: B) (B)(6), INRATIO: 3.1, INRATIO: 3.2, INRATIO: 3.5, REFERENCE: 3.27, BIAS THRESHOLD: 2.27 - 4.27, %CV: 6.37. RETENTION PRODUCTS PERFORMED AS EXPECTED. ALL REPLICATES WERE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY AND YIELDED A %CV OF LESS THAN (B)(4), 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. REGAIN STRIP TESTING RESULTS MET ACCURACY AND PRECISION CRITERIA. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. (B)(4). DUE TO THIS LOT OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B)(4) NO FURTHER ACTION IS REQUIRED AT THIS TIME. 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 INRATIO RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2013. INRATIO: 1.6, LAB: 3.1. TIME BETWEEN TESTS: 30 MINUTES. CUSTOMER ADDED MULTIPLE DROPS OF BLOOD TO THE TEST STRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301204 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 K303866

    Patients

    Seq Age Sex Outcome Treatment
    1 LEVOTHYROXINE| COUMADIN