BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3063382 · Received April 11, 2013

    Report

    Report Number
    2027969-2013-00292
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER ISSUE, CUSTOMER DID NOT USE THE FIRST DROP OF BLOOD AND DID NOT APPLY SAMPLE IMMEDIATELY AFTER FINGERSTICK. THIS DELAY IN APPLICATION MAY HAVE PREMATURELY INITIATED CLOTTING AND ADVERSELY EFFECTED SAMPLE MIGRATION, FLOW AND SATURATION. DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: (B)(6) 2013; INRATIO 2.1; REFERENCE 4.2; MEAN 3.15; CONFIDENCE LIMITS 1.9-4.6. 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. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 300671 ON (B)(6) 2012. RESULTS AS FOLLOWS: DONOR (B)(6): INRATIO 1.8, 2.0, 1.7; REFERENCE 2.0; BIAS THRESHOLD 1.00 - 3.00; %CV 8.33. DONOR (B)(6): INRATIO 2.4, 2.4, 2.6; REFERENCE 2.39; BIAS THRESHOLD 1.39 - 3.39; %CV 4.68. ALL REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN 16%. PRECISION CRITERIA HAS BEEN MET. NO FURTHER INFORMATION IS NECESSARY. ANALYSIS OF THE CLIENT'S DATA FROM INRATIO AND REFERENCE TESTS REVEALED THAT TEST RESULT COMPARISON MET ACCURACY CRITERIA. THE CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT WAS EXPECTED TO BE RETURNED, THEREFORE, RETAIN PRODUCTS WERE USED FOR INVESTIGATION TESTING. THE RETAIN 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). NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECTED TO TRACKING AND TRENDING. THERE IS NO CORRECTIVE ACTION AT THIS TIME, AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO INR RESULTS IN COMPARISON TO THE LABORATORY INR RESULTS. RESULTS AS FOLLOWS: DATE (B)(6) 2013; INRATIO INR 2.1; LABORATORY INR 4.2. THE TIME BETWEEN TESTING WAS FOUR HOURS. REPORTEDLY, THE SAMPLE WAS NOT APPLIED IMMEDIATELY AFTER FINGERSTICK, THE FIRST DROP OF BLOOD WAS NOT USED AND A REPEAT STICK WAS PERFORMED ON THE SAME FINGER. ADDITIONALLY, THE PATIENT EXPERIENCED ABNORMAL BRUISING AND EXTENDED BLEEDING AFTER THE FINGER STICK. THERAPEUTIC RANGE 3.2 - 3.5 FOR PATIENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155110 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 300671

    Patients

    Seq Age Sex Outcome Treatment
    1 Other COUMADIN| PLAVIX| HEPARIN FLUSH SAME DAY AT 11 AM| PERCOCET