BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2626911 · Received June 23, 2012

    Report

    Report Number
    2122870-2012-01533
    Event Type
    Malfunction
    Date Received
    June 23, 2012
    Date of Event
    May 29, 2012
    Report Date
    May 29, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED NON-REPRODUCIBLE HIGH TROPONIN I (ACCU TNI) PATIENT RESULTS ACROSS THREE DAYS. THIS REPORT IS ONE OF THREE REPORTS RELATED TO THREE EVENTS THAT OCCURRED ON THREE DAYS. THIS REPORT IS RELATED TO MDR# 2122870-2012-01531 AND MDR# 2122870-2012-01532.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (DXC 600I) GENERATED NON-REPRODUCIBLE HIGH TROPONIN I (ACCU TNI) PATIENT RESULTS. CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT QUALITY CONTROL (QC) HAS BEEN RECOVERING WITHIN RANGE. CUSTOMER REPORTED THAT THEY WERE USING ACCUTNI REAGENT LOT 218277 WITH ACCUTNI CALIBRATOR LOT 121451 ON THE DXC 600I SYSTEM. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE WASH CAROUSEL WAS EXTREMELY DIRTY. THE FSE CLEANED THE WASH CAROUSEL, INSPECTED THE INCUBATOR TRACK (WHICH WAS CLEAN) AND REINSTALLED THE ANALYTICAL MODULE. THE FSE ALSO PERFORMED ASSAY QC WHICH PASSED WITHIN THE CUSTOMER'S ESTABLISHED RANGES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR