BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1953302 · Received January 7, 2011

    Report

    Report Number
    2050012-2011-00087
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. QC WAS NOT RUN AFTER THE EVENT, PRIOR TO RECALIBRATION. QC AFTER RECALIBRATION IS WITHIN RANGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND INTERMITTENT BUBBLES IN THE BUFFER LINE. THE FSE REPLACED THE RATIO PUMP AND VERIFIED REPAIRS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSE LOW SODIUM (NA), POTASSIUM (K), AND CALCIUM (CALC) RESULTS THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER AFTER RECALIBRATION RESULTS WERE REPEATED, PRODUCING HIGHER RESULTS, AMENDED REPORTS WERE ISSUED. THE LAB HAS NOT HAD ANY REPORTS OF PATIENT IMPACT DUE TO THE LOW RESULTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1