BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIASON TREPONEMA ASSAY

    MDR report key: 3366581 · Received September 12, 2013

    Report

    Report Number
    2182595-2013-00002
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Date of Event
    August 16, 2013
    Report Date
    September 12, 2013
    Manufacturer
    DIASORIN S.P.A.
    Product Code
    LIP
    PMA / PMN Number
    K061247
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DIASORIN INC. RECEIVED A CUSTOMER COMPLAINT BY PHONE ON (B)(6) 2013 ALLEGING THEY HAD REPORTED FOUR FALSE POSITIVE TREPONEMA PATIENT RESULTS VIA THEIR LIS (LABORATORY INFORMATION SYSTEM). THE CUSTOMER OBSERVED A SET OF UNEXPECTED POSITIVE TREPONEMA RESULTS WHILE RUNNING THE DIASORIN LIAISON TREPONEMA ASSAY ON THE LIAISON ANALYZER. THE SAMPLES WERE TESTED AGAIN THE SAME DAY IN THE LIAISON TREPONEMA ASSAY AND WERE NEGATIVE. FOUR RESULTS (ID #'S: (B)(6)) WERE RELEASED TO THE LIS SYSTEM BEFORE THE CUSTOMER NOTICED THE UNUSUAL NUMBER OF POSITIVE RESULTS AND STOPPED THE ROUTINE. THE CUSTOMER SHUT DOWN AND RESTARTED THE LIAISON ANALYZER, REPEATED THE ENTIRE RUN AND ALL SAMPLES WERE NEGATIVE. THE CUSTOMER ALLEGES A PHYSICIAN CONNECTED TO THE LIS INFORMED A PATIENT (ID# (B)(6)) OF THE INITIAL POSITIVE TREPONEMA RESULTS BEFORE CONFIRMATORY TESTING WAS CONDUCTED AND THEN INFORMED THE PATIENT OF THE SUBSEQUENT NEGATIVE RESULT. ACCORDING TO THE GUIDELINE CDC MMWR REVERSE SEQUENCE SYPHILIS, INITIAL REACTIVE SAMPLES BY AN EIA/CIA METHOD SHOULD BE RETESTED WITH A QUANTITATIVE NON-TREPONEMAL TEST (RPR/VDRL) AND IN CASE OF DISCORDANT A RETEST WITH A TREPONEMAL METHOD (TP-PA) AS CONFIRMATORY TEST BEFORE REPORTING TO PATIENTS. DIASORIN CONDUCTED AN ANALYSIS OF THE CUSTOMER'S LIAISON ANALYZER LOG FILES WHICH REVEALED THAT DURING THE INITIAL LIAISON TREPONEMA ASSAY RUN ON (B)(6), 2013 THE LIAISON ANALYZER REPORTED AN ERROR PRIOR TO THE FALSE POSITIVE PATIENT SAMPLES BEING PROCESSED. THE MESSAGE "CATASTROPHIC ERROR" IS DOCUMENTED TO THE LIAISON USER MANUAL FOR SW 2.30, CHAPTER 19 "SYSTEM WARNINGS AND MESSAGES". CATASTROPHIC ERROR, REQUIRE THE USER TO RESTART THE ANALYZER AND THE COMPUTER (THE COMPLETE SYSTEM) SINCE THE INSTRUMENT HAS EXCEEDED THE CYCLE TIME AND MAY NOT BE ABLE TO PERFORM CORRECTLY THE REMAINING JOBS. THE LIAISON ANALYZER LOG FILES REVEALED THAT THE CUSTOMER DID NOT HEED THE ERROR MESSAGE AND CONTINUED TO RUN PATIENT SAMPLES WITHOUT SHUTTING DOWN AND RESTARTING THE INSTRUMENT. THE ERROR MESSAGE OCCURRED AT 10:01:22 AND THE INSTRUMENT WAS SHUT DOWN AT 10:59:17. THE FALSE POSITIVE TREPONEMA TEST RESULTS WERE PIPETTED AND MEASURED BETWEEN 10:01:22 AND 10:59:17. IN CONCLUSION DIASORIN'S INVESTIGATION DETERMINED THE ROOT CAUSE OF THE FALSE POSITIVE TREPONEMA RESULTS TO BE USER ERROR AS THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS PROVIDED. THE PERFORMANCE OF THE LIAISON TREPONEMA ASSAY IS NOT IN QUESTION.

    Description of Event or Problem · 1

    DIASORIN INC. RECEIVED A CUSTOMER COMPLAINT BY PHONE ON (B)(6) 2013 ALLEGING THEY HAD REPORTED FOUR FALSE POSITIVE TREPONEMA PATIENT RESULTS VIA THEIR LIS (LABORATORY INFORMATION SYSTEM). THE CUSTOMER ALLEGES A PHYSICIAN CONNECTED TO THE LIS INFORMED A PATIENT (ID # (B)(6)) OF THE INITIAL POSITIVE TREPONEMA RESULTS BEFORE CONFIRMATORY TESTING WAS CONDUCTED AND THEN INFORMED THE PATIENT OF THE SUBSEQUENT NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459169 LIASON TREPONEMA ASSAY LIP DIASORIN S.P.A. 113028X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other