BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2110838 · Received June 2, 2011

    Report

    Report Number
    2050012-2011-02093
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ENSURED THE REAGENT PROBE FITTINGS AND SYRINGE WERE TIGHT. CUSTOMER STATED THAT THE LEAKAGE WAS ON THE REACTION WHEEL COVER ALONG WITH THE REAGENT CAROUSEL ASPIRATION COVER. ON (B)(4) 2011, FIELD SERVICE ENGINEER (FSE) DID NOT NOTE EVIDENCE OF THE PROBE LEAKING. NO ADDITIONAL PROBE LEAK HAS BEEN REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT LEAK FROM BOTH REAGENT PROBES. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1