BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1924703 · Received December 14, 2010

    Report

    Report Number
    2050012-2010-01593
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM COLLECTED IN RED-TOP TUBES. NO SAMPLE ISSUE WAS NOTED. QC WAS ACCEPTABLE. NO OTHER CHEMISTRIES WERE AFFECTED AND NO SYSTEM ERROR MESSAGE WAS NOTED. SERVICE VISIT WAS NOT ORDERED AS THE ISSUE APPEARS TO BE SAMPLE RELATED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY HIGH TRIGLYCERIDES RESULT GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER FOR ONE PATIENT. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON THE SAME AND ON AN ALTERNATE INSTRUMENT PRODUCED LOWER RESULTS. IT IS UNKNOWN IF THE PATIENT TREATMENT WAS AFFECTED IN THIS EVENT. THE RISK OF SERIOUS INJURY WILL BE ASSUMED UPON RECUR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other