BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1628525 · Received March 3, 2010

    Report

    Report Number
    2027969-2010-00268
    Event Type
    Malfunction
    Date Received
    March 3, 2010
    Date of Event
    February 9, 2010
    Report Date
    March 3, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B) (6) 2010, 1ST INR = 1.1, 2ND INR = 3.2, MEAN = 2.15, SD = 1.48, %CV = 69.07. SINCE 69.07% CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADDITIONAL INVESTIGATION IS REQUIRED. DATA ANALYSIS OF CV% CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED BOTH TESTS DID NOT MEET PRECISION CRITERIA. NO PRODUCT IS EXPECTED TO BE RETURNED. PRECISION TEST DONE ON CASE# (B) (4) INDICATED PRODUCT DEFICIENCY WAS NOT ESTABLISHED IN RETAIN STRIPS LOT# 223042. THERE IS NO SUFFICIENT INFO TO DETERMINE THE ROOT CAUSE OF CUSTOMER'S TEST RESULT DISCREPANCY. AS OF 03/02/2010, 5 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT# 223042 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. INVESTIGATION RESULTS. PRECISION: FOR EACH PAIR OF REPLICATES FOR EACH SAMPLE ON STRIP OF 223042, MEAN AND STANDARD DEVIATIONS WERE CALCULATED. IN-HOUSE TEST RESULTS HAVE 2.84% AND 4.17%, RESPECTIVELY FOR EACH DONOR AND ARE LESS THAN 16%. BOTH SAMPLES PASS THE CRITERIA FOR PRECISION. NO DISCREPANT RESULT WAS ESTABLISHED ON IN-HOUSE METERS. NO FURTHER INVESTIGATION WILL BE PURSUED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010, INRATIO: 1.1, LAB: 3.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 223042

    Patients

    Seq Age Sex Outcome Treatment
    1