BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2042761 · Received April 6, 2011

    Report

    Report Number
    2050012-2011-00985
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT PROVIDED. NO SAMPLE ISSUES WERE NOTED. QC RESULTS REVEALED INSUFFICIENT REAGENT FLAG ON (B)(6) 2011 FOR SEVERAL CARTRIDGE CHEMISTRIES. QC RESULTS WERE WITHIN SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER FOR ION-SELECTIVE ELECTRODE (ISE) IMPRECISION AND REPLACED THE CAP PIERCER PERI-PUMP TUBE AND WICK. THE SYSTEM IS OPERATING PROPERLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ERRONEOUS LOW CARTRIDGE CHEMISTRY (CC) RESULTS GENERATED ON THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT RESULTS. SEVERAL CC WERE REPORTED RESULTS OF 1 OR 2 UNITS.

    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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1