BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2011170 · Received March 8, 2011

    Report

    Report Number
    2050012-2011-00676
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. THE CUSTOMER WAS HAVING PROBLEMS WITH CLOTS IN THE SAMPLES. BCI HOTLINE REVIEWED PROPER SAMPLE COLLECTION AND HANDLING WITH THE CUSTOMER. BCI FIELD SERVICE ENGINEER (FSE) FOUND FIBRIN STRANDS IN THE FLOW CELL. THE FSE REMOVED FLOW CELL AND CLEANED. THE FSE REPLACED CARBON BRIDGE AND VERIFIED REPAIRS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW SODIUM (NA) RESULTS AND ERRONEOUSLY ELEVATED CHLORIDE (CL) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM FOR TWO PATIENTS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. WHEN ANION GAPS ALERTED THE LABORATORY TO THE ISSUE, THE SAMPLES WERE RERUN AND THE REPEAT RESULTS WERE REPORTED. THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1