BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1612235 · Received February 4, 2010

    Report

    Report Number
    2027969-2010-00141
    Event Type
    Malfunction
    Date Received
    February 4, 2010
    Date of Event
    January 7, 2010
    Report Date
    February 4, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    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) 2010, INRATIO: 0.9, REFERENCE: 2.0, MEAN: 1.45, CONFIDENCE LIMITS: 1.1-1.9. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES FALL OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. STRIP ACCURACY TESTING REQUIRED AS PART OF THE COMPLAINT INVESTIGATION. RETAIN LOT #223042 WITH CODE BA7JS HAS BEEN INVESTIGATED. INVESTIGATION RESULTS: SEE SCANNED TABLE. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT THREE REPLICATES FOR BOTH SAMPLES FOR STRIP LOT #223042 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA; NO FURTHER INVESTIGATION WILL BE PURSUED. CUSTOMER RESULTS ANALYZED AND ACCURACY CONFIDENCE LIMITS WERE NOT MET. IN-HOUSE ACCURACY TEST PERFORMED WITH RETAIN STRIP, IN HOUSE METER, AND ACCURACY CRITERIA WAS MET. PRODUCT DEFICIENCY NOT ESTABLISHED. NO FURTHER INVESTIGATION WILL BE PURSUED. AS OF 02/04/2010, 6 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT # 223042 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. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED; CORRECTIVE ACTION NOT REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INRATIO: 0.9, LAB: 2.0.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1