BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I725 CLINICAL SYSTEM

    MDR report key: 980957 · Received January 16, 2008

    Report

    Report Number
    2122870-2008-00011
    Event Type
    Malfunction
    Date Received
    January 16, 2008
    Date of Event
    December 22, 2007
    Report Date
    January 16, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM CHECKS WERE IN SPECIFICATION IN LATE 2007. SAMPLE A WAS COLLECTED IN A LITHIUM HEPARIN TUBE WITHOUT GEL BY NON-LAB PERSONNEL IN THE ER. SAMPLE B WAS DRAWN IN A LITHIUM HEPARIN TUBE WITH GEL BY A LAB PHLEBOTOMIST. THE SPECIMENS WERE CENTRIFUGED AT 3,500 RPM FOR 5 MINS AT AMBIENT TEMP. SAMPLING WAS DONE FROM THE PRIMARY TUBES AND PROCESSED THROUGH THE CLOSED TUBE ACCESSING (CTA) SYSTEM. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) TO THE INSTRUMENT. THE FSE VERIFIED THE INSTRUMENT OPERATION PER ESTABLISHED PROCEDURES AND RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. THE FSE DISCUSSED IMPORTANCE OF PROPER SAMPLE HANDLING WITH CUSTOMER. ALTHOUGH PRE-ANALYTICAL SAMPLE HANDLING MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE 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 TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE SYNCHRON LX I725 INSTRUMENT FOR A SINGLE PT SAMPLE. AN INITIAL ACCU TNI RESULT WAS 0.08 NG/ML. THE ORIGINAL SAMPLE WAS TESTED FOR ACCU TNI ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND RESULTS WERE: 7.85 NG/ML AND 9.46 NG/ML. CUSTOMER THEN REPEATED TESTING ON THE LX I725 INSTRUMENT AND RESULTS WERE: 4.10 NG/ML AND 2.59 NG/ML. A FRESH SAMPLE WAS COLLECTED FROM THE PT AND TESTED ON THE DIFFERENT INSTRUMENT FOR ACCU TNI AND A RESULT OF 0.05 NG/ML WAS OBTAINED. BASED ON AVAILABLE INFO, ACCU TNI RESULT OBTAINED FROM SAMPLE B CORRELATED WITH THE PT'S CLINICAL CONDITION. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE HAVE BEEN NO REPORTS OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA