BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1445205 · Received August 21, 2009

    Report

    Report Number
    2050012-2009-00092
    Event Type
    Malfunction
    Date Received
    August 21, 2009
    Date of Event
    August 11, 2009
    Report Date
    August 21, 2009
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIMENS WERE ALL SERUM, SOME WERE SLIGHTLY ICTERIC. QC WAS WITHIN RANGE, EXCEPT FOR ONE LOW RESULT FOR MG AND ONE SUPPRESSED RESULT FOR PHS. CUSTOMER NOTED ISSUES WITH REAGENT PROBE AND PERFORMED CLEANING PER HOTLINE RECOMMENDATIONS. THE PROBLEM PERSISTED AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE INSTRUMENT AND REPLACED SEVERAL HARDWARE COMPONENTS. THE FSE CONDUCTED PERFORMANCE TESTING AND ALL RESULTS PASSED. UPON RECUR, THE HARDWARE FAILURES COULD CAUSE ERRONEOUS RESULTS ON ANY OR ALL CARTRIDGE CHEMISTRIES (CC), INCLUDING PIVOTAL CHEMISTRIES. TREATMENT COULD BE INITIATED OR WITHHELD BASED ON THE ERRONEOUS RESULTS OF PIVOTAL CHEMISTRIES THAT MAY CAUSE OR CONTRIBUTE TO SERIOUS INJURY TO THE PATIENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING LOW CARTRIDGE CHEMISTRY (CC) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS FOR MULTIPLE PATIENTS. THE LOW RESULTS WERE REPORTED OUT OF THE LAB. THE SPECIMENS WERE RE-TESTED AND AMENDED REPORTS WERE ISSUED. THE CUSTOMER INDICATED THAT THEY ARE NOT AWARE OF ANY CONSEQUENCES TO ANY OF THE PATIENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1