BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1970560 · Received January 25, 2011

    Report

    Report Number
    2050012-2011-00240
    Date Received
    January 25, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    2050012-01/11/2010-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QC WAS WITHIN LAB'S ESTABLISHED RANGES PRIOR TO THE EVENT. SERVICE PERFORMED ION-SELECTIVE ELECTRODE (ISE) MODIFICATION PER PCA REPORT NUMBER (B)(4). FDA RECALL NUMBER (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH SODIUM (NA) AND CHLORIDE (CL) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. THE CUSTOMER ONLY PROVIDED ONE NA EXAMPLE WHICH HAD INITIAL RUN RESULT OF 150 MMOL/L AND UPON REPEAT A 140 MMOL/L WAS OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1