BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2180154 · Received July 27, 2011

    Report

    Report Number
    2050012-2011-03824
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND PROVIDED INSTRUCTIONS FOR THE CUSTOMER TO INSPECT THE SYRINGES AND THE REAGENT PROBE CONNECTORS. THE CUSTOMER PRIMED THE INSTRUMENT MULTIPLE TIMES AND NO ADDITIONAL LEAK WAS OBSERVED. NO FURTHER LEAKING PROBE ISSUE WAS FILED AS OF(B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THE REAGENT PROBE A/B ON THEIR UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM WAS LEAKING. SYRINGES WERE REPLACED ON (B)(6) 2011. THE CUSTOMER STATED THAT NO ERRONEOUS PATIENT RESULTS WERE GENERATED. NO EFFECT TO PATIENT OR USER WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1