BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1620992 · Received February 25, 2010

    Report

    Report Number
    2027969-2010-00218
    Event Type
    Malfunction
    Date Received
    February 25, 2010
    Date of Event
    January 19, 2010
    Report Date
    February 25, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME OF COMPLAINT WAS FILED: INRATIO: 5.4, REFERENCE: 1.8, MEAN: 3.60, CONFIDENCE LIMITS: 2.0-5.0. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. REFERENCE VALUE FALLS OUTSIDE THE LIMITS, SO THE CRITERIA IS NOT MET AND THE VALUE IS DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. RETURNED METER AND OTHER LAB METERS WITH RETAINED STRIPS WERE TESTED. TEST RESULTS WERE COMPARED TO THE ONES FROM SYSMEX. CUSTOMER'S OBSERVATION WAS NOT REPRODUCED. PRODUCT DEFICIENCIES WERE NOT ESTABLISHED IN RETURNED METER AND RETAINED STRIPS. THERE IS NO SUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF COMPLAINT. AS OF 02/25/2010, EIGHTEEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #220392 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. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED. INVESTIGATION RESULTS FOR UNIT (B) (4). THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S WAS CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES FOR LOT 220392 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS WERE ESTABLISHED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INRATIO: 5.4, LAB: 1.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 220392

    Patients

    Seq Age Sex Outcome Treatment
    1 NI