BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 1203158 · Received October 17, 2008

    Report

    Report Number
    2122870-2008-00325
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN DAILY AND WAS WITHIN SPECIFICATIONS. A SYSTEM CHECK PERFORMED IN 2008 PARTIALLY FAILED. A REPEAT PASSING SYSTEM CHECK WAS NOT SUPPLIED BY THE CUSTOMER. THE SPECIMEN WAS LITHIUM HEPARIN PLASMA CENTRIFUGED AT 5,600 RPM FOR 5 MINUTES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A DIAGNOSTIC SYSTEM CHECK WHICH PARTIALLY FAILED. THE FSE FOUND ONE OF THE ASPIRATE PROBES TO BE DAMAGED, WHICH OCCLUDED THE TIP. THE FSE REPLACED THE SUBSTRATE AND ASPIRATE PROBES. A 2ND SYSTEM CHECK PASSED WITHIN SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO CLEAR ROOT CAUSE FOR THIS EVENT HAS 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 AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT GENERATED BY THE SYNCHRON LX I 725 INSTRUMENT FOR ONE PATIENT. THE INITIAL RESULT WAS 13NG/ML. THE SAMPLE WAS RE-TESTED AND REPEATED RESULT WAS "NEGATIVE" (THE ACTUAL RESULT IS NOT AVAILABLE). THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LAB. NO REPORTS OF DEATH, INJURY OR CHANGE TO PATIENT TREATMENT HAVE BEEN RECEIVED IN CONNECTION 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