BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1654104 · Received March 31, 2010

    Report

    Report Number
    2027969-2010-00381
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 31, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: 2.8, REFERENCE: 1.2, MEAN: 2.00, CONFIDENCE LIMITS: 1.3-2.7. 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. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. A 2.6, 2.2, 1.6 AND 1.5 INR ARE EXCLUDED FROM COMPARISON TESTS SINCE IT WAS PERFORMED ON DIFFERENT DAYS. SINCE THE TIME OF TEST EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PATIENT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. PREVIOUS INVESTIGATION ON STRIP LOT #222167 FROM A PREVIOUS CASE MET ACCURACY CRITERIA. NO FURTHER INVESTIGATION WILL BE PURSUED. INVESTIGATION RESULT: THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT THREE REPLICATES FOR BOTH SAMPLES FOR LOT #222167 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE ESTABLISHED ON RETURNED AND IN-HOUSE METER. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. CONCLUSION: BASED ON CUSTOMER'S REPORTED TEST DATA, DATA ANALYSIS OF MEAN CALCULATION REVEALED ACCURACY CRITERIA WAS NOT MET. NO PRODUCT IS EXPECTED TO BE RETURNED, RETAIN STRIP TEST DATA FROM A PREVIOUS CASE INDICATED PRODUCT DEFICIENCY NOT ESTABLISHED ON RETAIN STRIP LOT# 222167. PATIENT CONDITION AND MEDICATIONS MAY AFFECT INRATIO INR TEST. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF CUSTOMER'S TEST RESULT DISCREPANCY. AS OF 03/30/2010, 5 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #222167 YIELDING A COMPLAINT RATE OF 0.001%. 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: 2.8, LAB: 1.2. DATE: (B) (6) 2010, LAB: 1.5. DATE: (B) (6) 2010, LAB: 1.6. DATE: (B) (6) 2010, LAB: 2.2. DATE: (B) (6) 2009, LAB: 2.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 222167

    Patients

    Seq Age Sex Outcome Treatment
    1