BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM

    MDR report key: 2167327 · Received July 18, 2011

    Report

    Report Number
    2122870-2011-02233
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM. QC DATA WAS NOT SUPPLIED. CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO RUN A DIAGNOSTIC SYSTEM CHECK. THE SYSTEM CHECK FAILED THE UNWASHED %CV AND MEAN PORTIONS. DATA WAS NOT SUPPLIED. CTS INSTRUCTED THE CUSTOMER THROUGH INSPECTING THE TUBING FROM THE WASH BUFFER AND THE SUBSTRATE. ALSO TO CHECK THE ASPIRATE AND DISPENSE PROBES. THE CUSTOMER REPORTED EVERYTHING APPEARED CONNECTED AND DID NOT SEE ANY CRIMPED OR TWISTED TUBING. CTS WALKED THE CUSTOMER THROUGH CLEANING THE PRECISION VALVE AND REPEAT THE SYSTEM CHECK. THE SYSTEM CHECK WAS REPORTED TO STILL BE FAILING THE UNWASHED %CV. ON (B)(4) 2011, A BEC FIELD SERVICE ENGINEER (FSE) FOUND THAT MAIN PIPETTOR MOVED DOWN THE GANTRY TO THE ANALYTICAL MODULE, THE PIPETTOR SUPPLY TUBE EXTENDED AND LEAKED. FSE REPLACED THE PIPETTOR SUPPLY TUBE. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO ERRONEOUS HIGH AND LOW RESULTS ON SEVEN PATIENTS ON SEVERAL DIFFERENT ASSAYS, WHICH WAS GENERATED BY UNICEL DXC600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER ALSO REPORTED ON OBTAINING SEVERAL (B)(4) AND INDETERMINATE (IND) FALSE ON PATIENT RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE ERRONEOUS RESULTS WERE REPEATED ON THE SAME INSTRUMENT AND RESULTS WITHIN DIFFERENT CATEGORY WERE OBTAINED. PER CUSTOMER, NO DEATH OR INJURY TO PATIENT REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 600 I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1