BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 923333 · Received October 4, 2007

    Report

    Report Number
    2050012-2007-00025
    Event Type
    Other
    Date Received
    October 4, 2007
    Date of Event
    September 15, 2007
    Report Date
    October 4, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. THE SPECIMENS WERE COLLECTED IN LITHIUM HEPARIN PLASMA TUBES. THE CUSTOMER CONTACTED HOTLINE AND WAS INSTRUCTED TO PERFORM USER SERVICING PROCEDURES. HOWEVER, IT DID NOT RESOLVE THE PROBLEM. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE INSPECTED THE INSTRUMENT AND REPLACED A STIRRER MOTOR ASSEMBLY. THE HARDWARE IS BEING SENT TO BCI FOR INVESTIGATION. THERE HAVE BEEN NO FURTHER INCIDENTS OF LOW PHOSM RESULTS. A HARDWARE ISSUE, ADDRESSED BY THE FSE, MAY HAVE CONTRIBUTED TO THIS EVENT. 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 ERRONEOUSLY LOW PHOSPHORUS (PHOSM) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. NINE (9) ERRONEOUSLY LOW PHOSM RESULTS WERE REPORTED OUT OF THE LAB. THE RESULTS WERE FOR MULTIPLE PATIENTS AND WERE IN THE RANGE OF 0.5MG/DL TO 1.5MG/DL. THE ORIGINAL SAMPLES WERE RE-TESTED FOR PHOSM AND THE REPEATED RESULTS WERE IN THE RANGE OF 1.5MG/DL TO 3.8MG/DL. PER CUSTOMER, AT LEAST ONE PATIENT WAS TREATED BASED ON THE ERRONEOUSLY LOW PHOSM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Other