BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM)

    MDR report key: 2006690 · Received March 3, 2011

    Report

    Report Number
    2050012-2011-00642
    Date Received
    March 3, 2011
    Date of Event
    October 28, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM COLLECTED IN 13 X 75 MM TUBE. THE SAMPLES WERE ALIQUOTED BY THE AUTOMATE AND TESTED ON THE DXC 800. THE SAMPLE VOLUME USED IN THE TESTING IS 3 UL. THE CUSTOMER RAN THERAPEUTIC DRUG MONITORING (TDM) CONTROLS AFTER LOADING AND CALIBRATING REAGENT ONCE A DAY. ALL THE DAILY QC RESULTS MET ESTABLISHED RANGES. A BCI FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENTS AND DID NOT NOTE OR IDENTIFY ANY ISSUES A CLEAR ROOT CAUSE IS UNKNOWN FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW VANCOMYCIN RESULT ON ONE PATIENT GENERATED BY THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE HOSPITAL'S PHARMACIST IDENTIFIED THE RESULTS AS ERRONEOUS AND NOTIFIED THE CUSTOMER. THE SAMPLE WAS REPEATED AND HIGHER RESULT WAS OBTAINED. AMENDED REPORTS WAS INITIATED. PATIENTS' SAMPLES ARE PROVIDED. PATIENTS' TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM) DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC 880I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1