BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1627532 · Received March 2, 2010

    Report

    Report Number
    2027969-2010-00259
    Event Type
    Injury
    Date Received
    March 2, 2010
    Date of Event
    February 8, 2010
    Report Date
    March 2, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    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: 2.2; REFERENCE: 10.8; MEAN: 6.50. A 2 HOURS LAPSE BETWEEN TWO READINGS. THE MEAN IS >5.0 AND THE DIFFERENCE IS GREATER THAN 2.2. THESE RESULTS ARE CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. PREVIOUS INVESTIGATION ON STRIP LOT #221727 FROM A PRIOR CASE MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION WILL BE PURSUED. A 3.1 IS EXCLUDED FROM COMPARISON TESTING. SINCE TIME OF TEST EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. CONCLUSION: DATA ANALYSIS OF MEAN CALCULATION FROM COMPARISON TEST DATA ON 02/05/10 PROVIDED BY END-USER REVEALED INRATIO INR AND REFERENCE INR ARE OUTSIDE OF THE ACCEPTANCE REGION AND ARE CONSIDERED INACCURATE. NO PRODUCT IS EXPECTED TO BE RETURNED. PT'S CONDITION WAS NOT PROVIDED. THERE IS INSUFFICIENT INFO TO DETERMINE THE ROOT CAUSE. AS OF 03/01/2010, 19 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #221727 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. ONGOING 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; TIME: 5:30 PM; INRATIO: 3.1; LAB: -. (B) (6) 2010; 7:15 AM; 2.2; 10.8. PT WAS TOLD TO STOP TAKING HER COUMADIN DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100071 221727

    Patients

    Seq Age Sex Outcome Treatment
    1