BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 1033185 · Received April 23, 2008

    Report

    Report Number
    2122870-2008-00129
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 18, 2008
    Report Date
    April 23, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THREE LEVELS OF QC WERE WITHIN SPECIFICATIONS BEFORE AND AFTER THIS EVENT. SYSTEM CHECK FAILED IN 2008, 4 HOURS AFTER THE ERRONEOUS RESULT WAS OBTAINED. CUSTOMER PLACED A DIFFERENT SET OF ASPIRATES PROBES AND RERAN THE SYSTEM CHECK WHICH FAILED AGAIN. CUSTOMER RAN A 3RD SYSTEM CHECK ON THE NEXT DAY WHICH ALSO FAILED. THEY DISCOVERED THE WASH ARM WAS LOOSE WHICH WAS TIGHTENED WITH AN ALLEN WRENCH. THE SYSTEM CHECK WAS PERFORMED AGAIN AND RESULTS PASSED WITHIN SPECIFICATIONS. THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE AND WAS CENTRIFUGED AT 3,100 RPM FOR 7 MINUTES. THE SPECIMEN WAS PROCESSED THROUGH THE CLOSED TUBE ACCESSING (CTA) SYSTEM. NO ERRORS WERE POSTED TO THE EVENT LOG AND NO OTHER RESULTS WERE QUESTIONED AT THIS TIME. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED FOR THIS EVENT. A PRE-ANALYTICAL SAMPLE HANDLING PACKET WAS SENT TO CUSTOMER TO HELP EDUCATED THEIR STAFF. CUSTOMER IS NOW FOCUSING ON SAMPLE QUALITY AND IS REPEATING ALL ELEVATED ACCU TNI RESULTS BEFORE REPORTING OUT OF THE LAB. ALTHOUGH THE HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE COULD NOT BEEN DETERMINED. 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 AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT THAT WAS GENERATED BY THE SYNCHRON LX I 725 INSTRUMENT. A PT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 15.27 NG/ML WAS REPORTED OUT OF THE LAB. ON THE NEXT DAY A FRESH SAMPLE WAS COLLECTED FROM THE PT AND TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF 0.00NG/ML WAS OBTAINED AND REPORTED OUT OF THE LAB. THE CUSTOMER THEN TESTED THE ORIGINAL SAMPLE ON A DIFFERENT INSTRUMENT AND AN ACCU TNI RESULT WAS 0.01NG/ML. A CORRECTED REPORT HAS BEEN SUBMITTED. NO REPORT OF DEATH, INJURY, OR CHANGE TO PT TREATMENT HAVE BEEN RECEIVED IN CONNECTION TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA