BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2803637 · Received October 24, 2012

    Report

    Report Number
    2050012-2012-01756
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 29, 2012
    Report Date
    September 29, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIRTY MINUTES PRIOR TO THE EVENT, LEVEL 1 NA AND CA QC HAD BEEN OUT OF RANGE HIGH, AND CL WAS OUT OF RANGE LOW. LEVEL 2 QC WAS WITHIN RANGE, BUT ON THE EDGE OF THE LABORATORY'S RANGE. QC WAS RERUN IMMEDIATELY PRIOR TO THE PATIENT RUN AND CAME INTO RANGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE AND REPLACED THE CARBON BRIDGE WHICH RESOLVED THE ISSUE. INSTRUMENT PERFORMANCE WAS THEN VERIFIED. THE CAUSE OF THE ISSUE WAS THE CARBON BRIDGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THEIR UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM GENERATED FALSE HIGH NA, CL AND/OR CA RESULTS FOR 2 PATIENT SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, THE SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT IN THEIR LABORATORY AND THOSE RESULTS WERE REPORTED OUT. THERE WAS NO AFFECT TO PATIENTS WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR