BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2334124 · Received November 11, 2011

    Report

    Report Number
    2050012-2011-07417
    Event Type
    Malfunction
    Date Received
    November 11, 2011
    Date of Event
    October 22, 2011
    Report Date
    October 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011 CUSTOMER REPORTED THAT ON (B)(6) 2011 THE DXC 600 PRO INSTRUMENT (SN# (B)(4)) WAS GENERATING INTERMITTENT LOW CHOLESTEROL (CHOL) RESULTS ON QUALITY CONTROL AND PATIENT SAMPLE RUNS FOR FIVE (5) PATIENTS. CUSTOMER STATED THAT WHEN THEY RAN QUALITY CONTROLS THEY NOTICED THAT CHOL WAS LOW, SO THEY RECALIBRATED AND RERAN CONTROLS. AT FIRST CONTROLS WERE ACCEPTABLE FOR CHOL, BUT WHEN THEY RAN A PATIENT SAMPLE THE RESULT WAS LESS THAN 10 MG/DL. CUSTOMER STATED THAT THE THEY WERE USING CHOL REAGENT LOT M101643 FOR BOTH OF THE LABORATORY'S DXC 600 PRO INSTRUMENTS AND NO PROBLEMS WERE NOTED WITH DXC 600 PRO (SN#(B)(4)). CUSTOMER STATED THAT EVEN AFTER LOADING A NEW CARTRIDGE OF THE SAME LOT CHOL CONTROL RECOVERY WAS STILL LOW ON THE DXC 600 PRO (SN# (B)(4)). ON (B)(6) 2011 CUSTOMER RECALIBRATED THE NEW CHOL CARTRIDGE, AND THE QUALITY CONTROL RECOVERY HAS BEEN ACCEPTABLE. FIELD SERVICE ENGINEER (FSE) EXAMINED THE INSTRUMENT ON (B)(4) 2011. FSE NOTED THAT CHOL AND GLUCOSE QUALITY CONTROL ON THE DXC 600 PRO (SN#(B)(4)) ACCURACY AND PRECISION WAS OFF. FSE STATED THAT DURING TROUBLESHOOTING IT WAS DISCOVERED THAT THE SAMPLE PROBE WAS LEAKING SLIGHTLY AT THE TIP OF THE PROBE. FSE CHECKED CONNECTIONS AND FITTINGS AND THEN CHANGED OUT THE THREE WAY T-VALVE ALONG WITH THE REAGENT MIXER PADDLE DUE TO IT BEING SLIGHTLY BENT. FSE RAN A SMALL PRECISION RUN WITH PASSING RESULTS. FSE TURNED ANALYZER BACK OVER TO THE CUSTOMER FOR QUALITY CONTROL.

    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. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1