BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1568926 · Received December 10, 2009

    Report

    Report Number
    2027969-2009-01132
    Event Type
    Malfunction
    Date Received
    December 10, 2009
    Date of Event
    November 11, 2009
    Report Date
    December 10, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2009, 1ST INRATIO = 1.0 INR, 2ND INRATIO = 2.5 INR, MEAN = 1.75, SD = 1.06, %CV = 60.61. SINCE 60.61% CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. "BASED ON MEMORY, RECENT TEST CONFIRMS THAT CUSTOMER UTILIZE STRIP CODE (B)(4). ALL INRATIO RESULTS REPORTED BY CUSTOMER ARE REGISTERED ON MEMORY, BUT FAILED BOTH ACCURACY AND PRECISION CRITERIA. ADDITIONAL STRIP INVESTIGATION WAS PERFORMED ON RETAINED STRIP LOT 220375. ACCURACY TEST: SEE SCANNED TABLE. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT 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. PRECISION: FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT 220375, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS HAVE 2.44% AND 4.50%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULT WAS ESTABLISHED ON RETURNED AND IN-HOUSE METERS. NO FURTHER ACTION IS REQUIRED. ONE OF THE REF TEST VALUES WAS OVER 9.0. THESE IS HIGH DEGREE OF INACCURACY EXPECTED. ACCURACY DATA ANALYSIS FROM COMPARISON TESTS PROVIDED BY END-USER REVEALED PRODUCT TEST IS REQUIRED. RETURNED METER WERE TESTED AND TEST RESULTS INDICATED PRODUCT ACCURACY CRITERIA MET. THE OUTCOME OF COMPLAINT INVESTIGATION DOES NOT DEMONSTRATE A POTENTIAL DEFICIENCY OF A PRODUCT. CONTAMINATION WAS FOUND ON HEATER PLATE. IT MAY CAUSE HEATER CIRCUIT DAMAGE. THERE IS NO SUFFICIENT INFO TO DETERMINE THE ROOT CAUSE OF THE END-USER'S DISCREPANCY. FURTHER TESTING IS NOT REQUIRED AT THIS TIME. AS OF 12/10/2009, 11 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT #220408 YIELDING A COMPLAINT RATE OF 0.003%. 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.

    Description of Event or Problem · 1

    CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: INITIAL RESULT: 1.0. REPEAT: 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 220408

    Patients

    Seq Age Sex Outcome Treatment
    1