BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 3103653 · Received May 9, 2013

    Report

    Report Number
    2050012-2013-00329
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 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

    THE CUSTOMER INDICATED THAT QUALITY CONTROL (QC) WAS ACCEPTABLE BEFORE THE EVENT, AND OUT OF SPECIFICATIONS AFTER THE EVENT. THE CUSTOMER NOTICED THAT THE SCREWS FOR THE SYRINGE PUMP ASSEMBLY WERE NOT TIGHTENED DOWN. THIS CAUSED THE SYRINGE TO NOT MOVE PROPERLY WITHIN THE DRIVE. NO LEAKS WERE OBSERVED BY THE CUSTOMER. THE CUSTOMER WAS ABLE TO RESOLVE THE ISSUE BY TIGHTENING THE SCREWS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. INSTRUMENT IS CURRENTLY RUNNING WITHIN SPECIFICATION. FAILURE MODE IS RELATED TO HARDWARE AND ISSUE WAS RESOLVED BY CUSTOMER PERFORMING REPAIRS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER WAS GENERATING FALSE LOW PATIENT RESULTS FOR MULTIPLE CARTRIDGE CHEMISTRY (CC) ANALYTES. THE CUSTOMER PROVIDED THE DATA FOR TWENTY-NINE (29) PATIENT SAMPLES WITH DISCREPANT RESULTS FOR TRIGLYCERIDES, CHOLESTEROL AND HIGH DENSITY LIPOPROTEIN DEFICIENCY (HDLD) ANALYTES. INCORRECT RESULTS WERE REPORTED OUT OF THE LABORATORY. NO LEAKING WAS REPORTED. PATIENT TREATMENT WAS NOT IMPACTED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203542 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1