BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 3211843 · Received July 8, 2013

    Report

    Report Number
    2050012-2013-00465
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT NO MAINTENANCE HAD BEEN PERFORMED PRIOR TO THE LINE COMING OFF. THE CUSTOMER RE-ATTACHED THE ISE LINE #25 AND NO FURTHER LEAKING WAS OBSERVED. CALIBRATION AND QUALITY CONTROL (QC) PASSED WITHIN THE LABORATORY'S SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT SINCE THE CUSTOMER CORRECTED THE ISSUE. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING AN IONIZED SELECTIVE ELECTRODE (ISE) LEAK IN THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER HAD INITIALLY INFORMED BEC CUSTOMER TECHNICAL SUPPORT (CTS) THAT ALL THE ELECTROLYTES HAD FAILED CALIBRATION. UPON TROUBLESHOOTING THE CALIBRATION FAILURES, THE CUSTOMER FOUND LINE #25 WAS DISCONNECTED AT THE FLOWCELL. THIS CAUSED THE ISE ELECTROLYTE REFERENCE TO LEAK INTO THE ISE MODULE. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR STATED THAT SHE WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT DURING THIS EVENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311661 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1