BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX® I 725 CLINICAL SYSTEM

    MDR report key: 2110548 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01635
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT QC WAS ERRATIC. SERVICE WAS DISPATCHED AND ON-SITE FOR THIS EVENT ON (B)(4) 2011. THE FIELD SERVICE ENGINEER (FSE) REPLACED ALL DISPENSE PROBES AND CLEANED THE WASH CAROUSEL. THE FSE RAN A SYSTEM CHECK, WHICH PASSED THE SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A WASH BUFFER LEAK COMING FROM DISPENSE PROBE TUBING ON SYNCHRON LX I 725 CLINICAL SYSTEM. THE CUSTOMER NOTED A SPLIT IN THE DISPENSE PROBE TUBING. IT OCCURRED DURING A CALIBRATION ATTEMPT AND QC RUNS. THERE WAS NO PATIENT RESULT REPORTED WITH THIS EVENT. THERE WAS NO REPORT OF INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1