BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1640281 · Received March 15, 2010

    Report

    Report Number
    2027969-2010-00299
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    February 15, 2010
    Report Date
    March 15, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATE PROVIDED BY END-USER LOT: DATE: (B) (6) 2010, INRATIO 2 - 1ST INR: 1.7, INRATIO 1 - 2ND INR: 2.5, MEAN: 2.10, SD: 0.57, %CV: 26.94. SINCE 26.94% CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. VISUAL INSPECTION REVEALED CONTAMINATION ON HEATER PLATE. INRATIO RESULT PROVIDED BY THE CUSTOMER IS REGISTERED ON MEMORY, BUT DID NOT MEET PRECISION CRITERIA. STRIP INVESTIGATION WAS PERFORMED ON STRIP LOT #223042. DONOR 1, INR RETURN: 2.2, INR IN-HOUSE: 2.1, MEAN: 2.15, SD: 0.07, %CV: 3.29, RESOLUTION: PASS. DONOR 2, INR RETURN: 2, INR IN-HOUSE: 2, MEAN: 2, SD: 0.00, %CV: 0.00, RESOLUTION: PASS. FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP LOT #223042, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS HAVE 3.29% AND 0%, 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 INVESTIGATION WILL BE PURSUED. CONCLUSION: CUSTOMER RESULTS DIDN'T MEET PRECISION CRITERIA. THERAPEUTIC DONOR BLOOD WAS TESTED ON RETAIN STRIP WITH RETURNED METER, AND IN-HOUSE METER, AND PRECISION CRITERIA WAS MET. METER FUNCTION TESTING CRITERIA WAS MET. AS OF 3/12/2010, 6 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #223042 YIELDING A COMPLAINT RATE OF 0.004%. 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 ANOTHER INRATIO METER. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INRATIO2: 1.7, INRATIO: 2.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 223042

    Patients

    Seq Age Sex Outcome Treatment
    1