BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1810524 · Received August 20, 2010

    Report

    Report Number
    2050012-2010-00579
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM IS CALIBRATED EVERY 8 HOURS FOLLOWED BY A QC RUN AND THE QC RESULTS HAVE BEEN WITHIN THE LAB'S ESTABLISHED RANGES PRIOR TO THE EVENT. A BCI ENGINEER DECONTAMINATED THE SYSTEM AND REPLACED SOME HARDWARE. THERE HAVE BEEN NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING ERRONEOUS POTASSIUM (K) RESULTS. IT IS THE LABORATORY PROCEDURE TO RUN SAMPLES FOR K IN TRIPLICATE AND THE K RESULTS DID NOT CORRELATE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO AFFECT TO PATIENT TREATMENT.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1