BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 CLINICAL SYSTEM

    MDR report key: 2241846 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05093
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND REPLACED A VALVE WHICH RESOLVED THE LEAKING ISSUE. FES FOUND CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE ERRORS AND INSPECTED CRANES AND SOME RESISTANCE WAS FOUND ON THE VERTICAL MOVEMENT OF CC PROBE. FSE CLEANED AND LUBRICATED THE CRANE AND ALIGNMENTS WERE COMPLETED WHICH IMPROVED THE MOVEMENT. QC WAS TESTED AND NO PROBLEMS WERE OBSERVED. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT A REAGENT PROBE WAS DRIPPING AND THE SYNCHRON LXI 725 CLINICAL SYSTEM WAS PRODUCING PHOTOMETER ERRORS. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX®I 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LXI 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1