BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2180167 · Received July 27, 2011

    Report

    Report Number
    2050012-2011-03826
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 28, 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
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TROUBLESHOOTING WITH BEC CUSTOMER TECHNICAL SERVICE, THE CUSTOMER NOTICED THE LINE TO THE OBSTRUCTION DETECTION AND CORRECTION (ODC) DEVICE WAS LEAKING. BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE REPLACED THE MC SAMPLE CRANE TUBING ASSEMBLY. NO FURTHER PROBE LEAKING WAS REPORTED AS OF (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THEIR UNICEL DXC 800 SYNCHRON SYSTEM WAS GENERATING MODULAR CHEMISTRY (MC) PROBE OBSTRUCTION ERRORS. MEDICAL ATTENTION WAS NOT SOUGHT. NO EFFECT TO PATIENT OR OPERATOR WAS REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1