BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1573925 · Received December 23, 2009

    Report

    Report Number
    2027969-2009-01213
    Event Type
    Malfunction
    Date Received
    December 23, 2009
    Date of Event
    November 30, 2009
    Report Date
    December 23, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 METER = 0.9 INR, REFERENCE = 1.9 INR, MEAN = 1.40, CONFIDENCE LIMITS = 1.1-1.9. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. INRATIO VALUE FALLS OUTSIDE THE LIMITS, SO THE CRITERIA IS NOT MET AND THE VALUE IS DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIPS ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. INVESTIGATION RESULTS: BASED ON MEMORY, RECENT TEST CONFIRMS THAT CUSTOMER UTILIZE STRIP CODE WF1S8. THEN 0.9 INR IS REGISTERED ON MEMORY AND IS OUTSIDE THE CONFIDENCE LIMITS. STRIP INVESTIGATION WAS PERFORMED ON STRIP LOT #220375. 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 STRIP LOT #220375 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. CUSTOMER RESULTS ANALYZED AND ACCURACY CONFIDENCE LIMITS WERE NOT MET. IN-HOUSE INVESTIGATION WITH RETURNED METER. ACCURACY TEST PERFORMED WITH RETAIN STRIP, RETURN METER, AND ACCURACY CRITERIA WAS MET. METER MEMORY VERIFIED. METER FUNCTIONAL TEST PASSED. OTHER METER FUNCTIONS TESTED AND PASSED. PRODUCT DEFICIENCY NOT ESTABLISHED. FURTHER ACTION NOT REQUIRED. AS OF 12/23/2009, 8 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #220375 YIELDING A COMPLAINT RATE OF 0.002%. 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. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. CORRECTIVE ACTION NOT REQUIRED AS PRODUCT DEFICIENCY WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2009, INRATIO: 0.9, LAB: 1.9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 220375

    Patients

    Seq Age Sex Outcome Treatment
    1