BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1945114 · Received January 3, 2011

    Report

    Report Number
    2050012-2011-00023
    Date Received
    January 3, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QC WAS WITHIN LAB ESTABLISHED RANGES PRE AND POST EVENT. A BCI FIELD SERVICE ENGINEER (FSE) INSTRUCTED THE CUSTOMER TO REPLACE THE NA ELECTRODE. THE INSTRUMENT WAS RECALIBRATED AND HIGHER RESULTS WERE OBTAINED. ON (B)2010, THE FSE DECONTAMINATED THE INSTRUMENT, CLEARED A CLOG FROM THE EIC AND PERFORMED ISE MOD 10838. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE QC WAS WITHIN LAB ESTABLISHED RANGES PRE AND POST EVENT. A BCI FIELD SERVICE ENGINEER (FSE) INSTRUCTED THE CUSTOMER TO REPLACE THE NA ELECTRODE. THE INSTRUMENT WAS RECALIBRATED AND HIGHER RESULTS WERE OBTAINED. ON (B)(4) 2010, THE FSE DECONTAMINATED THE INSTRUMENT, CLEARED A CLOG FROM THE EIC AND PERFORMED ISE MOD 10838. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW SODIUM (NA) RESULTS FOR THIRTY THREE (33) PATIENTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. AMENDED REPORTS WERE INITIATED. PATIENT'S TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW SODIUM (NA) RESULTS FOR THIRTY THREE (33) PATIENTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN THE SAMPLES WERE REPEATED AND HIGHER RESULTS WERE OBTAINED. AMENDED REPORTS WERE INITIATED. PATIENTS 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 JGS BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1