BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2011144 · Received March 8, 2011

    Report

    Report Number
    2050012-2011-00677
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO THE EVENT. IT IS UNKNOWN IF QC WAS RUN AFTER THE EVENT BEFORE THE RECALIBRATION. WHEN THE ANION GAPS WERE FLAGGED AGAIN LATER, THE CUSTOMER CONTACTED BCI. BCI HOTLINE HAD THE CUSTOMER PERFORM ROUTINE FLOW CELL CLEANING. THE CUSTOMER USED A FRESH BOTTLE OF BLEACH. THIS RESOLVED THE PROBLEM. SERVICE CONFIRMED THAT THE CUSTOMER HAD PREVIOUSLY BEEN USING AN EXPIRED BOTTLE OF BLEACH TO PERFORM THE MAINTENANCE. THE FRESH IN-DATE BLEACH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRATIC SODIUM (NA) RESULTS GENERATED BY UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM. LOW ANION GAPS ALERTED THE LAB TO THE ISSUE WITH ERRATIC SODIUM RESULTS, AND THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SYSTEM WAS RECALIBRATED AND REPEAT TESTS WERE PERFORMED. THE REPEAT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JGS BECKMAN COULTER, INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1