BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2242245 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-04958
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 11, 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
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CLEANED THE REAGENT PROBE AND QC RECOVERED BETTER, BUT STILL RECOVERING ON THE LOW END. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE REPLACED THE CHEMISTRY CARTRIDGE (CC) SAMPLE PROBE AND PERFORMED REAGENT PROBE CARTRIDGE HEIGHT ALIGNMENT AND ROTARY ALIGNMENT. THE FSE TESTED OPERATION BY LOADING REAGENT PACKS WITH NO LEVEL SENSE ERRORS. CUSTOMER CALIBRATED TBIL AND RAN QC; ALL RESULTS WERE WITHIN ACCEPTABLE RANGE. THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING SUPPRESSED ERRONEOUS TOTAL BILIRUBIN (TBIL) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. CUSTOMER ALSO INDICATED THAT QC HAS BEEN RECOVERING LOW. THE ERRRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. NO IMPACT TO PATIENT WAS REPORTED FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1