BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2042742 · Received April 6, 2011

    Report

    Report Number
    2050012-2011-00970
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THE LEAK WAS OBSERVED AT THE GLUM CUP AFTER PERFORMING CUP MAINTENANCE. A BCI FIELD SERVICE ENGINEER (FSE) CLEANED RETAINER AND PORT WITH DI WATER. PUT EXISTING GLUCOSE SENSOR BACK ON ANALYZER. NO LEAKING OBSERVED. FSE PRIMED GLUM AND OBSERVED PROPER FILLING AND STIRRING. CALIBRATED GLUCOSE SENSOR. FSE STATED THAT THE CUSTOMER HAD SMALL AMOUNT OF REAGENT DRIP FROM AROUND RETAINER. FSE CALIBRATED THE GLUCOSE SENSOR AND VERIFIED INSTRUMENT PERFORMANCE PER ESTABLISHED PROCEDURE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO GLUCOSE CUP LEAK ON THE UNICEL DXC 600I SYNCHRON CHEMISTRY ANALYZER. NO INJURY OR EXPOSURE TO BIOHAZARDOUS MATERIALS 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