BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 1567522 · Received December 8, 2009

    Report

    Report Number
    2027969-2009-01152
    Event Type
    Malfunction
    Date Received
    December 8, 2009
    Date of Event
    November 11, 2009
    Report Date
    December 7, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    072727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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) 2009, INRATIO METER = 5.8 INR, REFERENCE = 4.0 INR, MEAN = 4.90, CONFIDENCE LIMITS = 2.8-7.2. TIME OF TESTING BETWEEN INRATIO AND REFERENCE IS NOT INDICATED. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. METER AND STRIPS ARE NOT EXPECTED TO BE RETURNED. FURTHER TESTING IS NOT REQUIRED AT THIS TIME. AS OF 11/24/2009, 9 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT # 220408 YIELDING A COMPLAINT RATE OF 0.002%. 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 IS NOT REQUIRED AT THIS TIME 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) 2009, INRATIO: 5.8, LAB: 4.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 220408

    Patients

    Seq Age Sex Outcome Treatment
    1