BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 3203182 · Received July 2, 2013

    Report

    Report Number
    2050012-2013-00452
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO OPERATOR MAINTENANCE HAD BEEN PERFORMED PRIOR TO INCIDENT. BEC CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO CLEAN THE PROBE AND RE-CALIBRATE. THE CUSTOMER CLEANED THE PROBE AND INFORMED CTS THAT QUALITY CONTROL (QC) RECOVERIES WERE OUT OF SPECIFICATION AND SEVERAL TESTS WERE FAILING CALIBRATION. LEAKING WAS STILL OBSERVED. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE OBSERVED THAT THE CC SAMPLE PROBE WAS LEAKING DURING THE PRIMING CYCLE. THE FSE FOUND THE CC SAMPLE PROBE WASH COLLAR VALVE WAS NOT ALLOWING ENOUGH VACUUM. THE FSE REPLACED THE CC SAMPLE PROBE AND THE CC SAMPLE PROBE WASH COLLAR VALVE. SYSTEM PERFORMANCE WAS VERIFIED. THE FSE CONFIRMED FAILURE MODE TO BE THE CC SAMPLE PROBE WASH COLLAR VALVE. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A CHEMISTRY CARTRIDGE (CC) SAMPLE PROBE LEAK IN THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE VOLUME OF THE LEAK WAS LESS THAN 1 ML AND WAS CONTAINED TO THE INSTRUMENT. CUSTOMER STATED BLOOD UREA NITROGEN (BUN), GLUCOSE, AND HIGH DENSITY LIPOPROTEIN (HDL) FAILED CALIBRATION FOR "SAMPLE NOT DETECTED" WHEN THE LEAK WAS DISCOVERED. 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
    302574 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