BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2819345 · Received November 5, 2012

    Report

    Report Number
    2050012-2012-01768
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    BECKMAN COULTER INC.
    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 SAMPLES WERE NORMAL IN APPEARANCE AND WERE RUN WITHIN 1 HOUR OF COLLECTION AND CENTRIFUGED AT 4400 RPM FOR 5 MINUTES IN A NON-REFRIGERATED CENTRIFUGE. QC PRIOR TO THE EVENT WAS WITHIN LAB'S ESTABLISHED RANGES. QC WAS NOT RUN AFTER THE EVENT. WHILE TROUBLESHOOTING THE ISSUE WITH BEC CTS (CUSTOMER TECHNICAL SUPPORT), THE CUSTOMER NOTED THAT THE ISE FLOWCELL DRAIN WAS NOT DRAINING. THE CUSTOMER WAS ABLE TO REMOVE A CLOT FROM LINE 36 DRAIN PORT, BUT THE DRAIN REMAINED OBSTRUCTED. APPROXIMATELY 75 TO 100 CC OF LIQUID LEAKED FROM THE DRAIN TRAY TO THE FLOOR. THE LEAK WAS NOT CONTAINED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, SCRUBS AND GLASSES. AND NO INJURY OR EXPOSURE WAS REPORTED. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND WAS ABLE TO FIND ADDITIONAL BLOCKAGE IN LINE 36. FSE REMOVED THE BLOCKAGE AND CLEANED THE VALVE AND PORTS AND VERIFIED INSTRUMENT PERFORMANCE. THE CAUSE OF THE LEAK WAS AN OCCLUDED LINE 36.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING FALSE CL, CO2 AND/OR CA RESULTS GENERATED BY THEIR UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE REPEATED ON ANOTHER INSTRUMENT IN THEIR LABORATORY AND THOSE RESULTS REPORTED OUT. THERE WAS NO AFFECT TO PATIENTS WITH REGARD TO THIS EVENT. THE CUSTOMER PROVIDED DATA FOR 7 PATIENTS AND STATED THERE WERE ERRONEOUS RESULTS ON 4 PATIENTS. BEC REVIEW OF THE DATA SHOWED THAT THE DIFFERENCES IN RESULTS FOR 2 OF THE 4 PATIENT SAMPLES WERE WITHIN ASSAY PRECISION CLAIMS AND NOT ERRONEOUS. THE CUSTOMER ALSO PROVIDED PRINTOUTS FROM 3 ADDITIONAL SAMPLES THAT HAD SUPPRESSED (NO RESULTS GENERATED) RESULTS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR