BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 3003019 · Received March 13, 2013

    Report

    Report Number
    2050012-2013-00170
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) NOTED BUBBLES IN THE RATIO PUMP, DEBRIS ON THE LOWER SEALS, AND VERTICAL GROOVES ON THE PISTON DUE TO WEAR. THE FSE REPLACED THE RATIO PUMP AND RESOLVED THE ISSUE. THE FSE ADDITIONALLY REPLACED THE CALCIUM ELECTRODE TIP TO RESOLVE CALIBRATION ISSUES; NO CALCIUM RESULTS WERE IMPACTED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED SODIUM RESULTS FOR QUALITY CONTROL (QC) AND TWO PATIENTS' SAMPLES INVOLVING THE UNICEL DXC 600 SYNCHRON SYSTEM. THE CUSTOMER STATED SODIUM QC AND PATIENT RESULTS WERE FIVE TO SIX POINTS HIGHER COMPARED TO AN ALTERNATE INSTRUMENT. CONTROL LEVEL 1 RECOVERED AT 159 MMOL/L. NO ERRONEOUS PATIENT RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104960 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1