BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2233729 · Received September 3, 2011

    Report

    Report Number
    2050012-2011-05143
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS SERUM AND COLLECTED IN A SST TUBE. THE CUSTOMER STATED THAT THE FRESH SAMPLE WAS SLIGHTLY CLOUDY, BUT DID NOT APPEAR LIPEMIC. IT WAS NOT UNTIL THE SAMPLE WAS FROZEN THAT IT APPEARED LIPEMIC. QC HAS BEEN WITHIN LABORATORY ESTABLISHED RANGES. NO OTHER PATIENT RESULTS YIELDED ERRONEOUSLY. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND EVALUATED THE INSTRUMENT, AND WAS FUNCTIONING TO SPECIFICATIONS. THIS EVENT IS A SAMPLE-SPECIFIC ISSUE. IT APPEARS THAT THE FALSE LOW NA RESULTS COULD HAVE BEEN CAUSED BY HYPERLIPIDEMIA, WHICH CAN INTERFERE WITH BEC'S INDIRECT ISE METHODOLOGY (AND FLAME PHOTOMETRY). OTHER COMPONENTS SPECIFIC TO THIS PATIENT MAY HAVE ALSO INTERFERED. THE INVESTIGATION IS ONGOING. THIS REPORT IS RELATED TO THE FOLLOWING MDRS THAT ARE BEING REPORTED ON DIFFERENT DATES AND ON DIFFERENT INSTRUMENTS FOR THE SIMILAR EVENTS THAT OCCURRED AT THIS CUSTOMER SITE: 2050012-2011-05138, 2050012-2011-05139, 2050012-2011-05140, 2050012-2011-05141, 2050012-2011-05142, 2050012-2011-05143, 2050012-2011-05144, 2050012-2011-05145.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING FALSE LOW SODIUM (NA) RESULTS ON A SINGLE PATIENT GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE SAME PATIENT SAMPLE HAD GIVEN A LOW DXC NA RESULT A MONTH PREVIOUSLY, ON (B)(6) 2011. THIS EVENT IS DOCUMENTED IN MDR2050012-2011-05139. THE CUSTOMER ALSO RAN THE SAME PATIENT SAMPLE ON TWO (2) OTHER INSTRUMENTS AND GENERATED THE SAME ERRONEOUSLY LOW RESULTS ON SEPARATE DATES. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER THE PHYSICIAN DID NOT BELIEVE THE RESULTS AND HAD THE SAMPLE ANALYZED BY AN ALTERNATE METHOD (ISTAT WHOLE BLOOD - DIRECT ISE METHODOLOGY) WITH A HIGHER RESULT. THE PHYSICIAN NOTIFIED THE LAB WHEN THE DXC NA RESULTS WERE REPORTED. TREATMENT WAS NOT INITIATED OR WITHHELD AS A RESULT OF THIS EVENT AS THE PHYSICIAN DID NOT BELIEVE THE ERRONEOUS RESULTS.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO