BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 972414 · Received December 20, 2007

    Report

    Report Number
    2122870-2007-00299
    Event Type
    Malfunction
    Date Received
    December 20, 2007
    Date of Event
    December 2, 2007
    Report Date
    December 20, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    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

    PER CUSTOMER, QC HAS BEEN ERRATIC PRIOR TO AND DURING THE EVENT. BASED ON QC CHARTS, THERE WERE NO QC REPEATS THAT RECOVERED WITHIN SPECIFICATIONS. A SYSTEM CHECK WAS PERFORMED MULTIPLE TIMES IN LATE 2007 BEFORE PASSING RESULTS WERE OBTAINED. CUSTOMER INDICATED THAT NO ERRORS WERE POSTED IN THE EVENT LOG. THE SAMPLES WERE COLLECTED IN LITHIUM HEPARIN, WITHOUT GEL PLASTIC TUBES AND WERE CENTRIFUGED AT 3,500 RPM FOR 5 MINS AT AMBIENT TEMP. THE SPECIMENS WERE SAMPLED FROM THE PRIMARY TUBES AND WERE PROCESSED THROUGH THE CLOSED TUBE ACCESSING (CTA) SYSTEM. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB ON TWO DAYS LATER: THE FSE REBUILT PRECISION PUMP. THE FSE CLEANED VALVES ON PRECISION AND WASH PUMPS. THE FSE REPLACED PRECISION PUMP ROTOR. THE FSE REPLACED SUBSTRATE PROBE DUE TO A KINK IN THE LINE. THE FSE VERIFIED INSTRUMENT OPERATION PER ESTABLISHED PROCEDURES AND RESULTS WERE WITHIN SPECIFICATIONS. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT, BUT HARDWARE ISSUES ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT. IN ADDITION, CUSTOMER CONTINUED TO RUN PT SAMPLES WITH FAILING QC.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) REGARDING AN ELEVATED TROPONIN (ACCU TNI) RESULT THAT WAS GENERATED BY THE SYNCHRON LX I 725 INSTRUMENT FOR A SINGLE PT SAMPLE. AN INITIAL ACCU TNI RESULT WAS 1.63NG/ML. THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A LOWER RESULT WAS OBTAINED (0.06NG/ML). THE CUSTOMER THEN RE-TESTED THE ORIGINAL SAMPLE ON THE LX I 725 INSTRUMENT AND REPEATED RESULT WAS 0.03NG/ML. A FRESH SAMPLE WAS COLLECTED FROM THE PT AND TESTED ON THE LX I 725 AND THE DIFFERENT INSTRUMENT AND ACCU TNI RESULTS OF 0.02NG/ML WERE OBTAINED FROM BOTH INSTRUMENTS. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB AND A CORRECTED REPORT WAS ISSUED. 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 I 725 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA