BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1882158 · Received October 25, 2010

    Report

    Report Number
    2050012-2010-01043
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO AND AFTER THE EVENT WAS WITHIN THE ESTABLISHED RANGES. THE CUSTOMER QUESTIONED WHY THE OBSTRUCTION DETECTION FEATURE DID NOT FLAG THE SAMPLE. A BCI FIELD SERVICE ENGINEER (FSE) CHECKED THE OBSTRUCTION DETECTION HARDWARE AND CONFIRMED IT WAS OPERATING TO THE SPECIFICATIONS. THE FSE EXPLAINED TO THE CUSTOMER THAT THE OBSTRUCTION DETECTION FEATURE IS DESIGNED TO DETECT TOTAL BLOCKAGE, BUT MAY NOT DETECT PARTIAL BLOCKAGE. BCI LABELING GIVES INSTRUCTIONS THAT THE SAMPLES WITH LESS THAN THE ANALYTICAL RANGES SHOULD BE CONFIRMED BY DILUTION. THE ROOT CAUSE FOR THIS EVENT WAS FIBRIN IN THE SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW PHENYTOIN (PHY) AND VALPROIC ACID (VPA) RESULTS OF <0.1 UG/ML GENERATED BY UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY, AND THE PHYSICIAN QUESTIONED THE RESULTS. THE LAB CHECKED THE SAMPLE AND FOUND A FIBRIN CLOT. SUBSEQUENT TESTING AFTER REMOVAL OF FIBRIN PRODUCED HIGHER RESULTS AND THE RESULTS WERE AMENDED TO 11.8 UG/ML FOR PHY AND 21.5 UG/ML FOR VPA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1