BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3051666 · Received April 10, 2013

    Report

    Report Number
    2050012-2013-00261
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE LAST MAINTENANCE PROCEDURE, INVOLVING THE REAGENT AND SAMPLE SYRINGE PLUNGERS, WAS PERFORMED ON (B)(4) 2013. THE CUSTOMER STATED THAT THE SYRINGE PLUNGER WILL BE REPLACED AND WILL FOLLOW CALIBRATION AND QC TO VERIFY INSTRUMENT PERFORMANCE. NO FURTHER CALLS HAVE BEEN MADE ON THIS ISSUE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER WAS FAILING SOME PORTIONS OF QUALITY CONTROL (QC) AND IRON/PHENOBARBITAL FAILED TO CALIBRATE. UPON TROUBLESHOOTING THE ISSUE, THE CUSTOMER DISCOVERED A BUBBLE IN THE REAGENT SYRINGE. THE CUSTOMER ALSO STATED THAT THE REAGENT PROBE DRIP TRAY WAS WET. THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES DURING THIS EVENT. THE MATERIAL SAFETY DATA SHEETS (MSDS) WAS NOT REVIEWED AND THE FACILITY DOES HAVE A RISK MANAGEMENT PLAN. THE CUSTOMER CLEANED THE LEAK. NO INJURIES WERE SUSTAINED BY ANY LAB PERSONNEL. THE OPERATOR IS NOT SEEKING ANY FORM OF MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152280 UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1