BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1845724 · Received September 27, 2010

    Report

    Report Number
    2050012-2010-00845
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 27, 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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISE SYSTEM IS ROUTINELY CALIBRATED EVERY 24 HOURS FOLLOWED BY A QC RUN. PRIOR TO THIS EVENT, THE K QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. NO OTHER CHEMISTRIES WERE AFFECTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH POTASSIUM (K) RESULT THAT WAS GENERATED BY THE UNICEL DXC 600 SYNCHRON CHEMISTRY ANALYZER. THE FALSE HIGH K RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THAT THERE WAS NO IMPACT OR CHANGE TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1