BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® SYSTEM

    MDR report key: 3791585 · Received May 6, 2014

    Report

    Report Number
    2050012-2014-00230
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE FOUND A CLOUDY WASH COLLAR AND REPLACED THE PART. THE FSE ALSO REPLACED A T-VALVE, A 100 UL SYRINGE, A CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE, AND A MIXER PADDLE. THE FSE PERFORMED NECESSARY ALIGNMENTS AND SUCCESSFULLY COMPLETED A PERFORMANCE VERIFICATION TEST FOR THE CC SAMPLE PROBE. THERE WERE NO FURTHER REPORTS OF LEAKS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBSERVING A CARTRIDGE CHEMISTRY SAMPLE PROBE LEAK ON A UNICEL DXC 600 PRO SYNCHRON SYSTEM WHILE PERFORMING A MAINTENANCE PROCEDURE. THE INSTRUMENT WAS NOT PROCESSING PATIENT SAMPLES AT THE TIME OF THE LEAK. THE CUSTOMER WAS WEARING A LAB COAT, GLOBES, AND SAFETY GLASSES AT THE TIME OF THE LEAK. THE LEAK WAS CONTAINED TO THE INSTRUMENT. THERE WERE NO REPORTS OF DIRECT CONTACT WITH THE LEAK OR OF INJURY AS A RESULT OF THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270588 UNICEL® DXC 600 PRO SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1