BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1724716 · Received June 9, 2010

    Report

    Report Number
    2027969-2010-00735
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 12, 2010
    Report Date
    June 9, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CB
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INR RESULTS PROVIDED BY THE CUSTOMER ARE PERFORMED MORE THAN THREE HOURS BETWEEN TWO READINGS. SINCE TIME OF TEST EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. DATA ANALYSIS WILL NOT BE PERFORMED AND NO FURTHER INVESTIGATION WILL BE PURSUED. CUSTOMER REPORTED RESULTS DID NOT INCLUDE DIRECT DATA COMPARISONS. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF CUSTOMER'S TEST RESULT DISCREPANCY. AS OF 06/09/2010, 20 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #220375 (STRIP CODE WF1S8) 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 REPORTS POOR PRECISION. RESULTS AS FOLLOWS: INRATIO: 3.0, 1.6. RESULTS WERE TAKEN ONE DAY APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071 WF1S8

    Patients

    Seq Age Sex Outcome Treatment
    1