BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2000537 · Received February 24, 2011

    Report

    Report Number
    2050012-2011-00494
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) REPLACED MODULAR CHEMISTRIES (MC) CUP DRAIN VALVE; HOWEVER, IT DID NOT FIX THE PROBLEM. THE FSE USED A 10% OF HYDROCHLORIC ACID (HCL) SOLUTION AND FORCED IT THROUGH THE CUP'S WASTE LINE. CUP NOW IS DRAINING CORRECTLY. THE FSE VERIFIED CALIBRATION AND QC RECOVERY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT ON THEIR UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS THE TOTAL PROTEIN (TP) CUP IS OVERFLOWING AND LEAKING REAGENT. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1