BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1930592 · Received December 16, 2010

    Report

    Report Number
    2122870-2010-00911
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN GREEN TOP TUBES AND CENTRIFUGED FOR 10 MINUTES AT 2,800 RPM. THE SPECIMENS WERE PROCESSED THROUGH THE CLOSED TUBE ACCESSION (CTA) VIA THE PRIMARY COLLECTION TUBES. QC PRIOR TO THE EVENT WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. A SYSTEM CHECK WAS PERFORMED ON 11/14/10 AND MET SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE REPLACED MULTIPLE PARTS. THE FSE CLEANED THE PRECISION AND WASH VALVES, VERIFIED ALIGNMENTS. ALL VERIFICATION TESTING MET PUBLISHED SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY ELEVATED TROPONIN (ACCUTNI) RESULTS, IN THE RISK STRATIFICATION RANGE, GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR TWO PATIENTS' SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. SUBSEQUENT TESTING ON THIS INSTRUMENT AND ON AN ALTERNATE METHODOLOGY PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1