BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2110812 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-01940
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT REPORT ANY CALIBRATION FAILURES OR SYSTEM ERRORS. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND INVESTIGATED WATER INTERMITTENTLY POOLING UNDER REAGENT PROBE AND PRECISION ISSUES WITH VARIOUS CARTRIDGE CHEMISTRIES. CUSTOMER HAD REPLACED CC SAMPLE SYRINGE BEFORE FSE ARRIVED. FSE ADJUSTED LAMP VOLTAGE, MADE APPLICABLE PHOTOMETER ADJUSTMENTS, REPLACED BOTH WASH VALVES BEHIND REAGENT PROBES, REPLACED REAGENT PROBE COLLAR WASH VALVE, ALL 3 WASH/VACUUM VALVES AND VARIOUS CUVETTES. FSE CALIBRATED ALL CC CHEMISTRIES AND RAN QC WHICH WAS ACCEPTABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRATIC RESULTS FOR CARTRIDGE CHEMISTRIES GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. PER CUSTOMER, THE ERRONEOUS RESULTS WERE ON CHOLESTEROL (HDLD) AND TOTAL BILIRUBIN (TBIL). THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREAMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1