BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1628405 · Received March 1, 2010

    Report

    Report Number
    2027969-2010-00245
    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
    CT, 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 COMPLAINT WAS FILED: DATE: (B)(6)2010; INRATIO METER = 2.74 INR; REFERENCE = 1.3 INR; MEAN = 2.02; CONFIDENCE LIMITS = 1.3-2.7. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. REFERENCE 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. DATA ANALYSIS OF MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED ACCURACY CRITERIA WAS NOT MET IN TWO OUT OF THREE COMPARISONS. NO PRODUCT IS EXPECTED TO BE RETURNED. PATIENT IS ON MEDICATION FOR HYPOTHYROIDISM AND IT MAY AFFECT INRATIO INR TEST RESULT. ACCURACY TEST DONE ON CASE# (B)(4) INDICATED PRODUCT DEFICIENCY WAS NOT ESTABLISHED IN RETAIN STRIP FROM LOT #221727. THERE IS NO SUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE. AS OF 02/26/2010, 16 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT #221727 YIELDING A COMPLAINT RATE OF 0.004%. 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. NO CORRECTIVE ACTION IS 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: 2.74; LAB: 1.3.

    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