BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2060347 · Received April 16, 2011

    Report

    Report Number
    2050012-2011-01162
    Event Type
    Malfunction
    Date Received
    April 16, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE INFORMATION ON SAMPLE COLLECTION AND STORAGE. PER BCI TROUBLESHOOTING, CUSTOMER REMOVED FIBRIN CLOTS FROM INSIDE GLUCOSE CUP. CALIBRATION AND QC PERFORMED TO SPECIFICATIONS AND SAMPLES RUN IN DUPLICATE MODE NOW MATCH. BSI FIELD SERVICE ENGINEER WAS DISPATCHED BUT DECLINED AFTER CUSTOMER WAS ABLE TO ROOT CAUSE THE EVENT. ROOT CAUSE IS ASSOCIATED WITH CUSTOMER ERROR IN PROCESSING CLEAN SAMPLES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THIRTY ONE (31) GLUCM SERUM PATIENT RESULTS DID NOT MATCH WHEN RUNNING IN DUPLICATE MODE ON THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. PATIENTS WERE BOTH MALE AND FEMALE. RESULTS WERE ERRATIC HIGH AND LOW. RESULTS WERE NOT REPORTED OUT OF THE LAB. NO REPORT OF DEATH OR INJURY HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1