BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1760299 · Received July 16, 2010

    Report

    Report Number
    2050012-2010-00449
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    July 4, 2010
    Report Date
    July 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ION SELECTIVE ELECTRODE (ISE) SYSTEM IS CALIBRATED IN EACH SHIFT. QC IS RUN WITH EVERY CALIBRATION. BEFORE THE EVENT, K QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. MULTIPLE PARTS WERE REPLACED, SOME OF THEM WERE DONE BY CUSTOMER. FSE SERVICED THE ANALYZER AND VERIFIED ITS PERFORMANCE. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ERRONEOUSLY HIGH POTASSIUM (K) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS FOR SEVERAL SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LAB. THE ORIGINAL SPECIMENS WERE RE-TESTED AND REPEATED RESULTS OBTAINED WERE LOWER FOR ALL PATIENTS. THE CUSTOMER HAS NOT RECEIVED ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1