BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2319236 · Received October 7, 2011

    Report

    Report Number
    2050012-2011-06047
    Event Type
    Malfunction
    Date Received
    October 7, 2011
    Date of Event
    January 7, 2010
    Report Date
    January 7, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS REQUESTED BUT WAS SUBSEQUENTLY CANCELED BY THE CUSTOMER. THE SYSTEM WAS EVALUATED BY THE CUSTOMER WHILE ON THE TELEPHONE WITH BCI CUSTOMER SERVICE. A ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT BUT APPEARS TO BE RELATED TO CONTAMINATION OF THE ION SELECTIVE ELECTRODES (ISES). THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM GAVE ERRONEOUSLY LOW SODIUM (NA), CHLORIDE (CL), CALCIUM (CALC) AND POTASSIUM (K) RESULTS FOR TWELVE PT SAMPLES. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. IT IS UNK IF THERE WERE ANY CHANGES TO PT TREATMENT AS A RESULT OF THIS EVENT. THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY. THE CUSTOMER STATED THAT THE SYSTEM QUALITY CONTROL (QC) WAS IN RANGE AT 1500 ON (B)(6) 2010. THE CUSTOMER DISCOVERED THAT CL, CALC, K RESULTS HAD DRIFTED LOW WHEN A QUALITY CONTROL (QC) WAS RUN AT 1900. THE SYSTEM WAS CALIBRATED AND A NEW QC WAS RUN. CL, CA, K RESULTS CAME UP BUT NA WAS LOW. THE CALIBRATION WAS REPEATED AND ALL OF THE ELECTROLYTES WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE CUSTOMER REPORTED THE 12 PTS RUN BETWEEN 1500 AND 1900 AND FOUND THAT ALL OF THE ELECTROLYTES INCREASED BY APPROXIMATELY 3-4 UNITS. THE CUSTOMER DID NOT SEND AMENDED REPORTS BECAUSE IT WAS NOT FELT THAT THE CHANGES WERE CLINICALLY SIGNIFICANT. THIS IS REPORT 11 OF 12 MEDWATCH REPORTS FILED FOR THIS EVENT FOR PT 11 OF 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK