BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 CLINICAL SYSTEM

    MDR report key: 2110825 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-01956
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING. CTS HAD CUSTOMER CHECK THAT REAGENT PROBES FITTING AND CC (CARTRIDGE CHEMISTRY) REAGENT SYRINGE ASSEMBLY. CUSTOMER STATED THAT THE CC REAGENT SYRINGE ASSEMBLY WAS LOOSE AND TIGHTENED IT. THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE SYNCHRON LXI 725 CLINICAL SYSTEM WAS LEAKING FROM THE REAGENT PROBES. NO INJURY 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1