BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1954576 · Received January 10, 2011

    Report

    Report Number
    2050012-2011-00052
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LAB TECH HAD DISABLED THE GLUCOSE MODULE 2 DAYS PRIOR TO THIS EVENT DUE TO IMPRECISION SEEN WITH PATIENT SAMPLES WHILE RUNNING IN THE DUPLICATE MODE. ANOTHER TECH ENABLED THE MODULE THIS DATE AND STARTED RUNNING GLUCOSE SAMPLES AGAIN. CALIBRATION WAS PERFORMED SUCCESSFULLY. QC WAS INTERMITTENTLY OUT OF ESTABLISHED RANGE. CUSTOMER HAD NOT REQUESTED SERVICE OR CALLED HOTLINE OVER THE WEEKEND WHEN THEY NOTICED IMPRECISION ISSUES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE REAGENT SYRINGE PUMP FOR THE GLUCOSE MODULE TO RESOLVE THE ISSUE. ROOT CAUSE APPEARS TO BE THE REAGENT PUMP TO THE GLUCOSE MODULE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING FALSE LOW GLUCOSE (GLUCM) RESULTS OBTAINED WHILE RUNNING PATIENT SAMPLES IN DUPLICATE MODE ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THE SAMPLES WERE RE-RUN ON OTHER METHOD AND OBTAINED RESULTS WERE REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1