BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1691142 · Received May 10, 2010

    Report

    Report Number
    2027969-2010-00565
    Event Type
    Malfunction
    Date Received
    May 10, 2010
    Date of Event
    April 14, 2010
    Report Date
    May 10, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B) (6) 2010, INRATIO: 2.0 INR, REFERENCE: 8.1 INR, MEAN: 5.05; (B) (6) 2010, INRATIO: 3.7 INR, LAB: 8.1 INR, MEAN: 5.90. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. A 7.1 INR IS EXCLUDED FROM COMPARISON TEST AND IS FROM DIFFERENT BRAND OF METER / PRODUCT. THE MEAN IS > 5.0 AND THE DIFFERENCE IS GREATER THAN 2.2. AND ONLY ONE INR VALUE IS GREATER THAN 5.0. THESE RESULTS ARE CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. PREVIOUS INVESTIGATION ON STRIP L/N: 222168 FROM PREVIOUS CASE HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED. DATA ANALYSIS REVEALED INRS REPORTED BY END USER DIDN'T MEET ACCURATE CRITERIA. NO PRODUCT IS EXPECTED TO BE RETURNED. ACCURACY TEST RESULTS FROM PREVIOUS CASE WITH RETAIN STRIPS MET ACCURACY. AS OF (B) (6) 2010, TWO DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT # 222168 YIELDING A COMPLAINT RATE OF 0.001%. DUE OT THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%) NO FURTHER ACTION IS REQUIRED AT THIS TIME. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION OR VIGILANCE REPORT IS REQUIRED AT THIS TIME. COMPARATIVE SAMPLE TESTING PERFORMED ON RETURNED PRODUCT. RETAINED STRIPS LN 222168 SELECTED FOR USE IN TESTING BASED UPON RECORD OF TESTS FOUND IN METER MEMORY. RESULTS AS DETAILED BELOW. SYSMEX RESULTS FOR BOTH DONORS ARE ABOVE 2.0. THE MINIMUM OF 2 OUT OF 3 REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS VARIANCE OF +/-1.0. NO FURTHER ACTION IS REQUIRED. FUNCTIONAL TESTING WAS PERFORMED WITH PASSING RESULTS.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INRATIO: 2.0, LAB: 8.1; (B) (6) 2010, INRATIO: 3.7, LAB: 7.3 (USING COAGUCHECK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 222168

    Patients

    Seq Age Sex Outcome Treatment
    1