BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2101393 · Received May 24, 2011

    Report

    Report Number
    2050012-2011-01892
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    December 27, 2010
    Report Date
    March 30, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGY
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, THE CUSTOMER CHANGED THE TG SETPOINT TO 217.3MG/DL, WHICH WAS THE CORRECT SETPOINT. ON (B)(6) 2010, THE CUSTOMER RAN A CALIBRATION WITH THE CORRECT TG SETPOINT, BUT FAILED DUE TO BACK-TO-BACK ERROR (IMPRECISION). LATER ON THE DAY, THE CUSTOMER RAN A CALIBRATION AGAIN AND WAS SUCCESSFUL. THE CUSTOMER INDICATES THEY DID NOT CHANGE THE SETPOINT OR RELOAD THE CALIBRATOR DISKETTE BETWEEN THE TWO CALIBRATIONS ON (B)(6) 2010. ON (B)(6) 2011, THE CUSTOMER NOTICED THE WRONG SETPOINT HAD BEEN IN USE SINCE (B)(6) 2010, AND CHANGED IT BACK TO 217.3 MG/DL. THE CUSTOMER THEN RERAN ALL PATIENTS FROM (B)(6) 2011 AND REVIEWED PATIENTS RUN BETWEEN (B)(6) 2010 AND (B)(6) 2011. THE CUSTOMER NOTIFIED PHYSICIANS OF ALL PATIENTS RUN BETWEEN (B)(6) 2011 AND (B)(6) 2011 THAT IF THE ISSUE WAS OF CONCERN, THE PATIENTS SHOULD BE REDRAWN FOR RETESTING. OF THOSE PATIENTS, THE PHYSICIANS IDENTIFIED 8 PATIENTS TO RETURN FOR REDRAW AND RETEST. AS OF THIS TIME, NONE OF THE 8 PATIENTS HAS RETURNED FOR RETESTING. THE CUSTOMER WILL RETAIN INFORMATION FOR BCI ON THOSE 8 PATIENTS IF THEY RETURN. IT IS ASSUMED THAT THE PATIENTS WHICH WERE NOT IDENTIFIED FOR REDRAW WOULD NOT HAVE BEEN IMPACTED BY THE DIFFERENCE IN TG RESULTS DUE TO THIS ISSUE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE FOR THIS EVENT WAS INCORRECT CALIBRATOR SETPOINT FOR TG. HOWEVER, THE ROOT CAUSE FOR THE INCORRECT SETPOINT BEING IN THE SYSTEM IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW TRIGLYCERIDE (TG) RESULTS GENERATED BY UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM FOR AN UNKNOWN NUMBER OF PATIENTS BETWEEN (B)(6) 2010 AND (B)(6) 2011. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE TESTS PERFORMED ON (B)(6) 2011 WERE REPEATED AND THE RESULTS ARE SHOWN IN THE ATTACHED FILE. EIGHT (8) PATIENTS, AMONG THOSE TESTED BETWEEN (B)(6) 2010 AND (B)(6) 2011, WERE IDENTIFIED BY PHYSICIANS AND REQUESTED TO RETURN FOR RE-TESTS. REPEAT TESTS HAVE NOT BEEN PERFORMED TO DATE. THERE WAS NO EFFECT TO THE PATIENTS TESTED ON (B)(6) 2011. THE EFFECT TO THE REST OF THE PATIENTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JGY BECKMAN COULTER, INC. DXC 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1