BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725 CLINICAL SYSTEM

    MDR report key: 2263769 · Received September 16, 2011

    Report

    Report Number
    2122870-2011-03762
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    September 28, 2009
    Report Date
    September 30, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE LEVELS OF QUALITY CONTROL (QC) WERE WITHIN ACCEPTABLE RANGES AT APPROX 10:30 AM ON (B)(6) 2009. A TSH RUN WAS COMPLETED AT 9:31 PM, (B)(6) 2009 ON REAGENT PACK #912696, SERIAL NUMBER (SN) (B)(4). ERRORS "REAGENT CAROUSEL MOTION ERROR" AND "ERROR MOVING THE SAMPLE CAROUSEL" BOTH OCCURRED AT 9:41 PM ON (B)(6) 2009. THE NEXT TSH RUN, WHICH PRODUCED THE ERRONEOUS TSH RESULTS, STARTED AT 10:28 PM, (B)(6) 2009, BEGINNING WITH THE FIRST REP FROM REAGENT PACK #912696, SN (B)(4), AND PRODUCED 14 CONSECUTIVE LOW TSH RESULTS. THE LAST SAMPLE WITH AN ERRONEOUS RESULT [14/1] WAS SAMPLED AT 7:00 AM AND RESULTED AT 7:46 AM. THE DAYSHIFT BEGAN AT APPROX 7:00 AM AND SAMPLES LOADED AFTER 7:00 AM CONTINUED TO RUN ON PACK# 912696, SN (B)(4) BUT BEGAN GENERATING NORMAL TSH RESULTS AND PASSING QC REPLICATES. SERVICE WAS NOT DISPATCHED. ROOT CAUSE WAS NOT DETERMINED, HOWEVER, THE INVESTIGATION DETERMINED THAT PROBABLE CAUSE WAS A MISLOADING OF THE REAGENT PRIOR TO THE TSH RUN THAT PRODUCED THE ERRONEOUS RESULTS, AND CORRECTED PRIOR TO THE TSH RUN THAT PRODUCES THE CORRECT RESULTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD¿L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS LOW ACCESS HYPERSENSITIVE HTSH (HUMAN THYROID-STIMULATING HORMONE) TEST RESULTS WERE OBTAINED FOR 14 PT SAMPLES WHEN USING THE SYNCHRON LXI 725 CLINICAL SYSTEM. THE INITIAL ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. ALL TESTING OCCURRED ON THE NIGHT SHIFT (B)(6) 2009. THE INITIAL TEST RESULTS WERE QUESTIONED BY THE PHYSICIANS. REPEAT ANALYSIS WAS PERFORMED. AMENDED REPORTS WERE ISSUED. THERE WAS NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT. THE CUSTOMER WAS NOT MADE AWARE OF ANY INJURY OR CHANGES IN PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI 725 CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS HYPERSENSITIVE HTSH