BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2128290 · Received June 15, 2011

    Report

    Report Number
    2050012-2011-02351
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CTS DIRECTED CUSTOMER TO TIGHTEN AND SECURE ALL THE FITTINGS AT THE CC SAMPLE AND CC REAGENT PROBES, THE FITTING AT THE CC SAMPLE AND CC REAGENT VALVE BLOCKS, AND THE SYRINGES. TROUBLESHOOTING WITH CTS RESOLVED THE ISSUE FOR THE CUSTOMER. CUSTOMER WAS INSTRUCTED TO MONITOR THE INSTRUMENT AND CALL CTS IF PROBLEM CONTINUED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) CUSTOMER TECHNICAL SUPPORT (CTS) OF OBTAINING SUPPRESSED RESULTS FLAGS (BLANK ABSORBANCE LOW, BLANK ABSORBANCE HIGH, OIR LOW, CC CUVETTE ERROR, NO VALUE DETECTED AND FLUID SENSE ERRORS) WHEN RUNNING QC ON THE UNICEL DXC 600 PRO INSTRUMENT. CUSTOMER STATED THAT ONLY THE CARTRIDGE CHEMISTRY SIDE IS AFFECTED, NOT THE MODULAR CHEMISTRY SIDE OF THE INSTRUMENT. CTS DIRECTED CUSTOMER TO CHECK FOR LEAKS ON THE CC SIDE OF THE INSTRUMENT. CUSTOMER FOUND THE CC REAGENT PROBE A DRIPPING AND FLUID POOLING AT THE BOTTOM OF THE CC REAGENT SYRINGE. NO REPORTS OF DEATH OR INJURY HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1