BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 1062392 · Received June 18, 2008

    Report

    Report Number
    2122870-2008-00193
    Event Type
    Other
    Date Received
    June 18, 2008
    Date of Event
    May 24, 2008
    Report Date
    June 18, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE PLASMA. THE CUSTOMER STATED TO CTS (CUSTOMER TECHNICAL SERVICE) THAT AT THE TIME ISSUES BEGAN, THEY FELT THE CAUSE WAS DUE TO A SPECIMEN HANDLING PROBLEM. HOWEVER, THE CUSTOMER CONFIRMED THE SAMPLE HANDLING ISSUE WAS CORRECTED AND THE NON-REPRODUCIBLE ELEVATED ACCU TNI RESULTS CONTINUED. CUSTOMER PROVIDED THAT THEY HAVE BEEN EXPERIENCING SYSTEM CHECK PROBLEMS BEFORE AND AFTER THE EVENT AND THEY ULTIMATELY FOUND THE SUBSTRATE PROBE TO BE LEAKING. A FIELD SERVICE ENGINEER (FSE) WAS ONSITE IN 2008: THE FSE COMPLETED A PM (PREVENTIVE MAINTENANCE) WHICH WAS DUE TO BE COMPLETED THE FOLLOWING MONTH. THE FSE NOTED A SUBSTRATE/BUFFER RESIDUE ON THE WASH CAROUSEL WHICH HE NOTED COULD HAVE CAUSED RV SPLASHING. THE FSE CLEANED THE WASH CAROUSEL AND PERFORMED A SYSTEM CHECK WHICH PASSED. THE FSE FURTHER VERIFIED THE PM BY PERFORMING SYSTEM CHECK WHICH PASSED. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED ACCU TNI RESULTS, GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM FOR MULTIPLE PATIENT SAMPLES. CUSTOMER VERBALLY PROVIDED RESULTS FOR ONE PATIENT'S SAMPLE AS AN EXAMPLE. THE INITIAL RESULT WAS 0.63 NG/ML. UPON REPEAT, A RESULT OF 0.07 NG/ML WAS OBTAINED AND WHEN TESTED ON A DIFFERENT INSTRUMENT, IT GAVE A RESULT OF 0.02 NG/ML. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE HAS BEEN NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA