BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1446188 · Received May 19, 2009

    Report

    Report Number
    2027969-2009-00341
    Event Type
    Malfunction
    Date Received
    May 19, 2009
    Date of Event
    April 22, 2009
    Report Date
    May 19, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    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: 2.7, LAB: 3.3, MEAN: 3.00, CONFIDENCE LIMITS: 1.8-4.2. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. 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. FUNCTIONAL TESTING IS NOT REQUIRED AT THIS TIME. PRODUCT DEFICIENCY COULD NOT BE ESTABLISHED. AS OF TODAY, NO PRODUCT IS EXPECTED TO RETURN. NO FURTHER INVESTIGATION WILL BE REQUIRED. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED TO DETERMINE IF FUTURE CORRECTIVE ACTION IS WARRANTED. AS OF 04/23/2009, 8 DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT # 080818 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. NO CORRECTIVE ACTION IS REQUIRED AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH INRATIO VERSUS LAB. INRATIO: 2.7, LAB: 3.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIM TIME TEST GJS BIOSITE INCORPORATED 0100007

    Patients

    Seq Age Sex Outcome Treatment
    1 NI