BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2644211 · Received July 7, 2012

    Report

    Report Number
    2050012-2012-01364
    Event Type
    Malfunction
    Date Received
    July 7, 2012
    Date of Event
    June 12, 2012
    Report Date
    June 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: WASH STATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT LEVEL 2 MULTIQUAL CONTROL HAS BOTTOMED OUT ON MULTIPLE CHEMISTRIES ON THE CARTRIDGE CHEMISTRY (CC) SIDE OF THE UNICEL DXC 600 SYNCHRON SYSTEM THE LAST TWO NIGHTS. CUSTOMER INDICATED THAT LEVEL 2 MULTIQUAL CONTROL WAS ACCEPTABLE WHEN REPEATED. CUSTOMER REPORTED THAT LEVEL 3 QUALITY CONTROL RAN DIRECTLY AFTER LEVEL 2 WAS ACCEPTABLE. CUSTOMER REPORTED THAT THE PROBLEM SEEMED TO HAVE STARTED AFTER THE NIGHT TECH REPLACED THE CAP PIERCER BLADE. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) CONFIRMED THE CAP PIERCER WAS LEAKING. THE FSE FOUND DEBRIS WAS PRESENT IN THE WASH STATION. THE FSE CLEARED THE DEBRIS FROM THE WASH STATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1