BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1628401 · Received March 1, 2010

    Report

    Report Number
    2027969-2010-00246
    Event Type
    Malfunction
    Date Received
    March 1, 2010
    Date of Event
    February 3, 2010
    Report Date
    March 1, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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: 4.7, REFERENCE: 1.5, MEAN: 3.10, CONFIDENCE LIMITS: 1.8-4.2. 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. INVESTIGATION: FUNCTIONAL TESTS WERE PERFORMED. BOTH TESTS FAILED ON SAMPLE INDICATOR ON. DURING THERMOMETER SENSING TEST, LED INDICATOR SIMULTANEOUSLY EMITTED WITH "APPLY SAMPLE" MESSAGE. VISUAL INSPECTION REVEALED CONTAMINATION ON HEATER PLATE. THE 4.7 INR IS REGISTERED ON MEMORY, BUT DID NOT MEET ACCURACY CRITERIA. STRIP INVESTIGATION WAS PERFORMED ON STRIP LOT# 220392. 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# 220392 ARE WITHIN THE ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON RETURNED AND IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA, AND THEN NO FURTHER ACTION IS REQUIRED. CONCLUSION: DATA ANALYSIS OF MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED REFERENCE INR WAS OUTSIDE OF THE LOWER CONFIDENCE LIMIT. ACCURACY TEST WAS PERFORMED WITH RETURNED METER/STRIPS AND LAB METER. RESULTS WERE COMPARED TO THE ONES FROM SYSMEX. COMPARISON OF THE IN-HOUSE TESTS INDICATED ACCURACY CRITERIA HAD BEEN MET. PRODUCT DEFICIENCIES WERE NOT ESTABLISHED IN RETURNED METER/STRIPS. METER FUNCTIONAL TEST FAILURE MAY INDICATE TESTING PLATFORM SENSOR AND/OR SOFTWARE DID NOT CORRECTLY DETECT TESTING SIGNALS. THERE IS INSUFFICIENT INFO TO DETERMINE THE ROOT CAUSE. AS OF 02/25/2010, 20 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. 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: 4.7, LAB: 3.5.

    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