BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1903898 · Received November 20, 2010

    Report

    Report Number
    2050012-2010-01227
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 24, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC HAS BEEN INCONSISTENT. PER HOTLINE REQUEST, THE CUSTOMER FLUSHED AND RECALIBRATED THE MODULAR CHEMISTRY (MC) PROBE AND RAN QC WHICH WAS NOT WITHIN ACCEPTABLE RANGE. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE MC SAMPLE: PROBE, WASH COLLAR, SYRINGE, SYRINGE VALVE. FSE REMOVED AND INSPECTED THE FLOW CELL AND DISCOVERED FIBROUS MATERIAL. FSE PERFORMED BIOBURDEN TESTING AND FOUND BACTERIAL GROWTH IN THE INTERNAL MC SIDE OF THE REAGENT AND TUBING. FSE DECONTAMINATED THE UNIT AND REPLACED ALL ISE TUBING AND CARBON BRIDGE. PART REPLACEMENT AND SYSTEM DECONTAMINATION RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH SODIUM (NA) RESULT GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE HIGH RESULT (165 MMOL/L) TRIGGERED A CRITICAL RERUN THAT RESULTED IN LOWER VALUE (141 MMOL/L) BEING OBTAINED. THE SAMPLE WAS NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER, JGS BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1