BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 1033188 · Received April 23, 2008

    Report

    Report Number
    2122870-2008-00132
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 7, 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 PERFORMED IN 2008 WAS WITHIN SPECIFICATIONS. NO ERRORS WERE POSTED TO THE EVENT LOG. THE SAMPLE WAS COLLECTED IN 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 OTHER RESULTS WERE QUESTIONED AT THIS TIME. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE INSTRUMENT AND DID NOT ADDRESS ANY HARDWARE ISSUES. THE FSE PERFORMED VERIFICATIONS PROTOCOL AND ALL TESTING PASSED WITHIN SPECIFICATIONS. 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. 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 BACKMAN COULTER, INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT THAT WAS GENERATED BY THE SYNCHRON LX I 725 INSTRUMENT. A PT SAMPLE (1) WAS TESTED FOR ACCU TNI AND A RESULT OF 2.26NG/ML WAS REPORTED OUT OF THE LAB. ON THE SAME DAY, A FRESH SAMPLE (2) WAS COLLECTED FROM THE PT AND TESTED FOR ACCU TNI ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB, AND A RESULT OF 0.02NG/ML WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB. A FOLLOWING DAY CUSTOMER RE-TESTED THE ORIGINAL SAMPLE AND REPEATED RESULT WAS 0.02NG/ML. A CORRECTED REPORT HAS BEEN SUBMITTED. THE CUSTOMER THEN RETESTED THE 2ND SAMPLE AND AN ACCU TNI RESULT WAS 0.01NG/ML. A 3RD SAMPLE GAVE A RESULT OF 0.02NG/ML AND WAS REPORTED OUT OF THE LAB. NO REPORTS 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