BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1903975 · Received November 20, 2010

    Report

    Report Number
    2050012-2010-01316
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    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

    QC PRIOR TO AND AFTER THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND PER FSE, VISUAL INSPECTION SHOWED PROBABLE CONTAMINATION. FSE COLLECTED CULTURES USING ESTABLISHED PROTOCOL AND PERFORMED FULL ISE DECONTAMINATION WITH SODIUM HYPOCHLORITE ACCORDING TO ESTABLISHED PROCEDURES. CALIBRATION AND PERFORMANCE VERIFICATION THEN PERFORMED, MET STATED LIMITS. FSE EDUCATED THE CUSTOMER ON PROPER ISE REAGENT CHANGING AND CHLORIDE ELECTRODE AND PORT MONTHLY CLEANING PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE FALSE LOW RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND THE RESULTS WERE AMENDED. THE CHLORIDE (CL) RESULTS WERE ALSO LOW BUT NONE OF THE RESULTS WERE AMENDED. THERE WAS NO AFFECT TO PATIENT TREATMENT AS A RESULT OF 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1