BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1891886 · Received November 5, 2010

    Report

    Report Number
    2050012-2010-01182
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISE SYSTEM IS ROUTINELY CALIBRATED EVERY 24 HOURS. ISE QC IS RUN EVERY 12 HOURS. PRIOR TO THE EVENT, QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REPLACED THE SODIUM REFERENCE AND MEASURING ELECTRODES AND THE POTASSIUM TIP, CARBON BRIDGE AND MODULAR CHEMISTRIES (MC) SAMPLE PROBE. THE ISE SYSTEM WAS CALIBRATED. AS OF (B)(4) 2010, THE ISE SYSTEM WAS OPERATING WITHIN SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. PER CUSTOMER, NO FALSE RESULTS WERE REPORTED OUT OF THE LAB. PATIENT RESULTS WERE REQUESTED BUT WERE NOT AVAILABLE. THERE WAS NO EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1