BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 2032124 · Received March 28, 2011

    Report

    Report Number
    2122870-2011-00855
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 27, 2011
    Report Date
    February 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES. SERVICE WAS DISPATCHED ON 03/01/2011. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A SYSTEM CHECK, AND IT FAILED DUE TO A HIGH FLIER IN THE WASHED PORTION. THE FSE REPLACED THE ASPIRATE PROBES AND REPEATED THE SYSTEM CHECK, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE THEN PERFORMED A HIGH SENSITIVITY SYSTEM CHECK, WHICH FAILED. THE FSE REPLACED THE INCUBATOR BELT, REACTION VESSEL (RV) CLIPS AND PERFORMED ALL ASSOCIATED ALIGNMENTS. THE FSE REPEATED THE HIGH SENSITIVITY SYSTEM CHECK, WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. ALTHOUGH SOME HARDWARE ISSUES WERE ADDRESSED, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULT, ABOVE THE AMI CUTOFF, GENERATED BY SYNCHRON LXI 725 CLINICAL SYSTEM. THE RESULT WAS REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED A RESULT WITHIN THE NORMAL REFERENCE RANGE. IT IS UNKNOWN IF THE PATIENT TREATMENT WAS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX® I 725 CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER MMI BECKMAN COULTER, INC. LXI 725 (ACCESS 2I) NA

    Patients

    Seq Age Sex Outcome Treatment
    1