BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3100555 · Received May 8, 2013

    Report

    Report Number
    2050012-2013-00328
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MZV
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER VERBALLY STATED THAT QUALITY CONTROL (QC) PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. THE CUSTOMER ALSO STATED THAT THE QC WAS RUNNING LOW, BUT WITHIN RANGE. IT IS UNKNOWN IF THE LOW, BUT WITHIN RANGE QC WAS RUN PRIOR TO OR AFTER THE EVENT. SYNCHRON QC LEVELS 2 AND 3 WERE LOW, OUT OF LAB-ESTABLISHED RANGES (UNKNOWN IF THIS WAS PRIOR TO OR AFTER THE EVENT). DATA WAS NOT PROVIDED. THE CUSTOMER REPLACED THE K ELECTRODE TIP AND STATED THAT SYNCHRON QC WAS STILL LOW, BUT WITHIN RANGE. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED BOTH THE NA ELECTRODES AND THE K ELECTRODE TIP. THE FSE VERIFIED INSTRUMENT PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED FALSE LOW POTASSIUM (K) RESULTS FOR TWO (2) PATIENT SAMPLES. THE FALSE RESULTS WERE REPORTED OUT OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT AND THE RESULTS WERE AMENDED. THE CUSTOMER IS ONLY QUESTIONING THE K RESULTS. PATIENT TREATMENT WAS NOT IMPACTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202067 UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MZV BECKMAN COULTER DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1