BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2246199 · Received August 19, 2011

    Report

    Report Number
    2122870-2011-03004
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    September 24, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(6) 2008, TO INVESTIGATE THE EVENT. THE CUSTOMER STATED TO FSE THAT MAINTENANCE WAS DONE IMPROPERLY AND ONE OF THE ASPIRATE PROBES WAS NOT REPLACED CORRECTLY. WASH BUFFER (WB) WAS SPILLED INTO THE ANALYTICAL UNIT AND DRIED LEAVING A WHITE SALT RESIDUE THAT COULD EASILY HAVE FALLEN INTO A REACTION VESSEL DURING WASHING. THE FSE REPLACED THE MIXER PULLEY THAT HAD BECOME CORRODED FROM THE WB AND THOROUGHLY CLEANED THE ANALYTICAL UNIT. THE FSE DOCUMENTED THAT HE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. CUSTOMER ERROR IS THE ROOT CAUSE FOR THIS EVENT. MDR# 2122870-2008-318 DOCUMENTS THE PATIENT RESULTS FOR PATIENT 1. THIS IS 2 OF 2 SEPARATE MDR REPORTS RELATED TO 2 PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT ON DIFFERENT DAYS. REFERENCE MDR NUMBER 2122870-2008-38 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 THROUGH OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN I) RESULT IN THE RISK STRATIFICATION RANGE FOR TWO PATIENTS. THE RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER RE-RAN THE SAMPLES AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI