BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1648431 · Received April 1, 2010

    Report

    Report Number
    2050012-2010-00150
    Event Type
    Malfunction
    Date Received
    April 1, 2010
    Date of Event
    March 1, 2010
    Report Date
    April 1, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE LAB'S ESTABLISHED RANGES. SERVICE WAS NOT DISPATCHED FOR THIS EVENT, SINCE IT IS BELIEVED TO BE A SAMPLE SPECIFIC ISSUE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR 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 A FALSE HIGH CHOLESTEROL AND A FALSE LOW HDLD RESULT ON ONE PATIENT GENERATED BY THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEMS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB AND WERE QUESTIONED BY THE PHYSICIAN. THE ORIGINAL SAMPLE WAS RE-TESTED IN TWO DIFFERENT REFERENCE LABS AND THE RESULTS WERE AMENDED. UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD, BUT PHYSICIAN QUESTIONED THE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1