BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CLINICAL SYSTEM

    MDR report key: 2216767 · Received August 18, 2011

    Report

    Report Number
    2050012-2011-04620
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011, BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SERVICE ON THE INSTRUMENT. THE FSE FOUND THE ODC (OBSTRUCTION DETECTION AND CORRECTION) LEAKING FROM THE BOTTOM DUE TO BROKEN SEALS. THE FSE REPLACED ODC ASSEMBLY AND CALIBRATED. THE FSE PERFORMED PROBE ALIGNMENT. MC CHEMISTRIES WERE CALIBRATED AND QC WAS RUN. ALL RESULTS PASSED THE SPECIFICATIONS. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT MODULAR CHEMISTRY (MC) SAMPLE PROBE ON SYNCHRON LX20 PRO CLINICAL SYSTEM WAS SPRAYING LIQUID. THE CUSTOMER USED PPE TO CLEAN THE AREA. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. LX20 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1