BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3240897 · Received July 17, 2013

    Report

    Report Number
    2027969-2013-00575
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2013,, INRATIO: 1.6, REF: 2.0, REF. (LAB): 2.1, MEAN: 1.90, CONFIDENCE LIMITS: 1.3-2.7. DATE: (B)(6) 2013,, INRATIO: 1.5, REF: 2.0, REF. (LAB): 2.1 MEAN: 1.87, CONFIDENCE LIMITS: 1.3-2.7. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. INR REPORTED HAVE MET THE CRITERIA FOR ACCURACY. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 303081 ON (B)(4) 2013. RESULTS AS FOLLOWS: DONOR (B)(4): INRATIO: 2.7, 2.7, 2.9, REFERENCE: 3.28, BIAS THRESHOLD: 2.28-4.28, %CV: 4.17; DONOR (B)(4): INRATIO: 3.6, 3.2, 3.3, REFERENCE: 3.27, BIAS THRESHOLD: 2.27-4.27, %CV: 6.18. ALL REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN (B)(4). ACCURACY AND PRECISION CRITERIA HAVE BEEN MET. NO FURTHER INVESTIGATION IS NECESSARY. 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. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND PRECISION CRITERIA. PRODUCT PERFORMED AS EXPECTED. AS REVIEWED ON (B)(4) 2013, (B)(4) DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #308061, YIELDING A COMPLAINT RATE OF (B)(4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLD 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. THERE IS NO CORRECTIVE ACTION REQUIRED AT THIS TIME, AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO2 INR RESULT VS POINT OF CARE (POC) INR RESULT AND LABORATORY INR RESULT. THE PATIENT WAS TRAINED ON DEVICE ON (B)(6) 2013. THE PATIENT'S DAUGHTER, WHO IS A NURSE, TESTED THE PATIENT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013, INRATIO2 INR: 1.6, POC INR: 2.0, LABORATORY INR: 2.1, REPEAT TESTS PERFORMED: INRATIO2 INR: 1.5, POC INR: 2.0. THE TIME BETWEEN THE LABORATORY TESTING AND THE INRATIO2 TESTING WAS 2.5 HOURS. THE TIME BETWEEN THE INRATIO AND POC TESTING WAS IMMEDIATE. THE FIRST COMPARISON WAS PERFORMED USING THE SAME FINGER. THE FIRST DROP OF BLOOD WAS APPLIED TO THE INRATIO2 DEVICE AND THE SECOND DROP OF BLOOD WAS APPLIED TO THE POC DEVICE. THE SECOND COMPARISONS WAS PERFORMED USING DIFFERENT FINGERS. THERAPEUTIC RANGE WAS 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
    332420 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 308061

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN| COAGUCHEK