BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1412364 · Received July 13, 2009

    Report

    Report Number
    2050012-2009-00074
    Event Type
    Malfunction
    Date Received
    July 13, 2009
    Date of Event
    June 18, 2009
    Report Date
    July 13, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THE EVENT, THE ION SELECTIVE ELECTRODE (ISE) SYSTEM CALIBRATED AND ALL ISE QC RESULTS WERE WITHIN THE LAB'S E STABLISHED RANGES.THE OPTIONAL FLOW CELL CLEANING PROCEDURE WHICH WAS SENT TO ALL CUSTOMERS IN JULY 2008 WAS NOT INSTITUTED BY THE CUSTOMER. HOTLINE RECOMMENDED THAT THE CUSTOMER USE THE OPTIONAL FLOW CELL CLEANING PROCEDURE.A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE DECONTAMINATED THE FLOW CELL AND TRAINED THE USER ON ISE AND CARTIDGE CHEMISTRIES (CC) SAMPLE PROBE MAINTENANCE.A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    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.THE INITIAL RESULTS OF 5.5MMOL/L AND 6.1MMOL/L WERE REPORTED OUT OF THE LAB.THE PHYSICIAN QUESTIONED THE RESULTS AND REQUESTED THE SAMPLES TO BE RE-TESTED.THE RE-PEATED RESULTS WERE LOWER (4.5 AND 5.8MMOL/L, RESPECIVELY), AND AMENDED REPORTS WERE ISSUED.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