BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1612229 · Received February 4, 2010

    Report

    Report Number
    2027969-2010-00142
    Event Type
    Malfunction
    Date Received
    February 4, 2010
    Date of Event
    January 11, 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: 1.0, REFERENCE: 4.0, MEAN: 2.50, CONFIDENCE LIMITS: 1.6-3.4. 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#222166 WITH CODE UA293 HAS BEEN INVESTIGATED. INVESTIGATION RESULTS: ACCURACY, 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 222166 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON 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. TIME ELAPSE BETWEEN RESULTS NOT INDICATED. IF THE TIME ELAPSED EXCEEDS 3 HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. IN-HOUSE ACCURACY TEST PERFORMED WITH RETAIN STRIP, IN-HOUSE METER, AND ACCURACY CRITERIA WERE MET. PRODUCT DEFICIENCY NOT ESTABLISHED. NO FURTHER INVESTIGATION WILL BE PURSUED. AS OF 2/04/2010, 1 DISCREPANT RESULT COMPLAINT WAS REPORTED FOR LOT # 222166 YIELDING A COMPLAINT RATE OF 0.005%. 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 AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INRATIO: APPROX 1.0; LAB: APPROX 4.0. CALLER DID NOT KNOW EXACT INR RESULTS, PATIENT SPECIFICS, OR TIME INTERVAL BETWEEN METER TEST AND LAB DRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 222166

    Patients

    Seq Age Sex Outcome Treatment
    1