BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1589785 · Received January 18, 2010

    Report

    Report Number
    2027969-2010-00063
    Event Type
    Malfunction
    Date Received
    January 18, 2010
    Date of Event
    December 23, 2009
    Report Date
    January 18, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    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) 2009, INRATIO: 1.1, REFERENCE: 2.2, MEAN: 1.65, CONFIDENCE LIMITS: 1.2-2.3. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. INRATIO VALUE FALLS OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUE IS DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. INVESTIGATION: INRATIO RESULTS PROVIDED BY THE CUSTOMER ARE REGISTERED ON MEMORY. STRIP INVESTIGATION WAS PERFORMED ON LOT #221727. INVESTIGATION RESULT. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES FOR LOT# 221727 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE ESTABLISHED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED NO ALL TEST VALUES ARE WITHIN THE CONFIDENCE LIMITS. THE RESULT OF ACCURACY TESTS WITH RETURNED METER/LAB METERS/SYSMEX COULD NOT REPLICATE CUSTOMER'S OBSERVATION. ACCURACY CRITERIA HAS BEEN MET. METER MEMORY RECORD WAS REVIEWED MULTIPLE NES TEST RESULTS. METER INVESTIGATION REVEALED SAMPLE CONTAMINATION. THERE IS INSUFFICIENT INFO TO DETERMINE THE ROOT CAUSE OF CUSTOMER'S DISCREPANCY. AS OF 01/15/2010, 5 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT# 221727 YIELDING A COMPLAINT RATE OF 0.001%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%) NO FURTHER ACTION IS REQUIRED AT THIS TIME. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2009, INRATIO: 1.10, LAB: 2.20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 221727

    Patients

    Seq Age Sex Outcome Treatment
    1