BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1589189 · Received January 13, 2010

    Report

    Report Number
    2027969-2010-00033
    Event Type
    Malfunction
    Date Received
    January 13, 2010
    Date of Event
    December 15, 2009
    Report Date
    January 13, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    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) 2009; INRATIO METER = 1.5 INR; REFERENCE = 3.31 INR; MEAN = 2.41; CONFIDENCE LIMITS = 1.6-3.4. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. INRATIO VALUE FALLS OUTSIDE THE LIMITS, SO THE CRITERIA ARE NOT MET AND THE VALUE IS DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. TESTING WAS PERFORMED USING RETAINED STRIPS, IN-HOUSE METERS AND TWO DONORS. (B) (4) THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INR'S AND SYSMEX INR'S ARE CALCULATED. AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH SAMPLES FOR STRIP LOT 221727 ARE WITHIN ALLOWABLE BIAS. NO DISCREPANT RESULTS ARE PRODUCED ON IN-HOUSE METERS. THESE MEET THE ABOVE CRITERIA; NO FURTHER ACTION IS REQUIRED. AS OF 01/13/2010, 2 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT# 221727 YIELDING A COMPLAINT RATE OF 0.0007%. 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.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B) (6) 2009; INRATIO: 1.5; LAB: 3.31. CORRELATION STUDY BY NEW TECH THAT JUST STARTED USING METER A MONTH AGO. COMPARISON WAS DONE WITHIN ONE AND A HALF HOURS. NO PT MEDICATION INFO OR HEMATOCRIT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 221727

    Patients

    Seq Age Sex Outcome Treatment
    1