BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2256789 · Received August 19, 2011

    Report

    Report Number
    2122870-2011-02938
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    August 28, 2008
    Report Date
    August 28, 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

    THE FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO INVESTIGATION THE EVENT. THE FSE INSPECTED THE INSTRUMENT AND FOUND THAT THE MIXER PULLEY FOR DISPENSE PROBE #3 HAD ALL BUT SEIZED AND HAD SPREAD METAL FILINGS THROUGH THE ANALYTICAL UNIT. EXAMINATION OF PAST QUALITY CONTROL (QC), PRECISION CHECKS, CALIBRATIONS AND SYSTEM CHECKS SHOWED THAT INTERMITTENT PROBLEMS HAD BEEN OCCURRING PRIOR TO THE GENERATION OF THE FALSE POSITIVE RESULTS. THE FSE REPAIRED THE INSTRUMENT AND PERFORMED A PRECISION RUN WHICH SHOWED GOOD PRECISION. THIS IS TWO OF TWO SEPARATE MDR REPORTS RELATED TO THREE PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT ON DIFFERENT DAYS. REFERENCE MDR NUMBERS 2122870-2011-02902, 02938 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN I) RESULTS IN THE RISK STRATIFICATION RANGE FOR THREE PTS. THE RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER RE-ALIQUOTED AND RE-CENTRIFUGED THE SAMPLES PRIOR TO RERUNNING THEM AND THE RESULTS WERE WITHIN THE REFERENCE RANGE. A CORRECTED REPORT WAS SENT OUT OF THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT 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