BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2060456 · Received April 18, 2011

    Report

    Report Number
    2050012-2011-01199
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM, NO SAMPLE ISSUES WERE NOTED. QC HAS BEEN ACCEPTABLE. A REVIEW OF QC AND CALIBRATIONS IN PROSERVICE DID NOT REVEAL ANY OBVIOUS ISSUES. ON (B)(6) 2011, SERVICE INSTRUCTED THE CUSTOMER TO RUN A LOW LEVEL PRECISION RUN. NO SERVICE VISIT WAS NEEDED; THE ISSUE WAS RESOLVED BY THE CUSTOMER RECALIBRATING THE SYSTEM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ERRONEOUS LOW TOTAL BILIRUBIN (TBIL) RESULTS GENERATED ON THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER UNITS. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED AND HIGHER RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1