BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1657085 · Received April 13, 2010

    Report

    Report Number
    2050012-2010-00176
    Event Type
    Malfunction
    Date Received
    April 13, 2010
    Date of Event
    March 18, 2010
    Report Date
    April 12, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS CALIBRATED EVERY 24 HOURS, AND QC SAMPLES ARE RUN EVERY 8 HOURS. PRIOR TO THE EVENT, QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE OPERATOR NOTICED A SMALL BREAK IN TUBING NEAR THE LID OF ONE OF THE ISE SOLUTIONS. THE CRACKED TUBING WAS REPLACED. THE FIELD SERVICE ENGINEER (FSE) VERIFIED THAT THE SYSTEM WAS OPERATING WITHIN SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH SODIUM (NA) AND CHLORIDE (CL) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. THE RESULTS WERE REPORTED OUT OF THE LAB. THE SPECIMEN WAS RE-TESTED AND OBTAINED RESULTS WERE LOWER FOR BOTH ANALYTES. CUSTOMER ONLY PROVIDED THE CORRECTED RESULTS. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1