BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 923334 · Received October 4, 2007

    Report

    Report Number
    2050012-2007-00026
    Event Type
    Other
    Date Received
    October 4, 2007
    Date of Event
    August 29, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO QC PROBLEM WAS REPORTED. THE INSTRUMENT DID NOT GENERATE ERROR MESSAGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE REVIEWED THE EVENT AND DISCOVERED THAT THE INCORRECT CRP RESULTS WERE ALL RUN IN CUVETTE #6. PER FSE, NO OTHER ANALYTES WERE AFFECTED. THE FSE CONDUCTED A TEST TO USE ALL THE CUVETTES AND ONLY CUVETTE #6 FAILED TWICE. BASED ON OBTAINED DATA, THE FSE REALIZED A SIGNAL-PROCESSING ISSUE RATHER THAN CUVETTE ISSUE. A SMART MODULE 81 (PHOTOMETER ANALOG) WAS REPLACED WHICH RESOLVED THE PROBLEM. THE SMART MODULE HAS BEEN RETURNED TO BCI FOR INVESTIGATION. 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 FALSELY LOW C-REACTIVE PROTEIN (CRP) RESULTS GENERATED BY THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEMS FOR FOUR PATIENTS. PATIENT A: SPECIMENS WERE TESTED BETWEEN TWO DAYS IN 2007. CRP RESULTS WERE IN THE RANGE OF "<5MG/DL" TO 174MG/DL. PATIENT B: SPECIMENS WERE TESTED IN 2007. CRP RESULTS WERE IN THE RANGE OF "<5MG/DL" TO 202MG/DL. HISTORICAL RESULTS FOR PATIENT B WERE: 218MG/DL AND 194MG/DL. PATIENT C: SPECIMENS WERE TESTED IN 2007. CRP RESULTS WERE IN THE RANGE OF "<5MG/DL" TO 317MG/DL. HISTORICAL RESULTS FOR PATIENT C WERE IN THE RANGE OF 88MG/DL-240MG/DL. PATIENT D: SPECIMENS WERE TESTED IN 2007. CRP RESULTS WERE IN THE RANGE OF "5MG/DL"TO 223MG/DL. PATIENT TREATMENT WAS NOT AFFECTED UPON RESULTS OBTAINED IN THIS EVENT.

    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