BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 1638803 · Received March 18, 2010

    Report

    Report Number
    2027969-2010-00319
    Event Type
    Injury
    Date Received
    March 18, 2010
    Date of Event
    February 15, 2010
    Report Date
    March 18, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 THE TIME COMPLAINT WAS FILED: DATED: (B) (6) 2010, INRATIO: 3.4, REFERENCE: 9.41, MEAN: 6.41. 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. ADDITIONAL INVESTIGATION IS REQUIRED. NOTE: THE 3.92 IS EXCLUDED FROM COMPARISON TEST 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. VISUAL INSPECTION REVEALED CONTAMINATION ON HEATER PLATE. STRIP INVESTIGATION WAS PERFORMED ON STRIP LOT #220392. THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INRS ARE 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, AND THEN NO FURTHER ACTION IS REQUIRED. CONCLUSION: THE COMPARISON OF INRATIO AND REFERENCE RESULTS OF USER; THE CONFIDENCE LIMITS ARE UNABLE TO DETERMINE, AND ARE CONSIDERED INACCURATE. DATA 3.92 IS NOT VALID FOR COMPARISON. TIME ELAPSED EXCEEDED THREE HOURS. 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. PATIENT HAS THYROID CONDITION, WHICH MAY AFFECT TEST RESULTS. THERAPEUTIC DONOR BLOOD WAS TESTED ON RETAIN STRIP WITH RETURNED METER AND SYSMEX; ACCURACY CRITERIA WAS MET, VISUAL INSPECTION OBSERVED CONTAMINATION ON HEATER PLATE. AS OF 3/18/2010, TWENTY FIVE DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #220392 (B) (4). DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (B) (4), 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 AS PRODUCT DEFICIENCY WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6)2010, INRATIO: 3.4, LAB: 9.41. DATE (B) (6) 2010, LAB: 3.92. PATIENT HAS BRUISES IN GROIN AREA AND WAS TOLD NOT TO TAKE COUMADIN DOSE FOR TWO DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 220392

    Patients

    Seq Age Sex Outcome Treatment
    1 Other