BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2142184 · Received May 26, 2011

    Report

    Report Number
    2050012-2011-01644
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    August 19, 2009
    Report Date
    August 28, 2009
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BECKMAN COULTER HOTLINE TECHNICAL SUPPORT DISCUSSED WITH THE CUSTOMER HOW TO MONITOR ISE RESULTS AFTER MAINTENANCE PROCEDURES ARE COMPLETED. PREANALYTICAL EFFECTS WERE DISCUSSED WITH THE CUSTOMER. HOWEVER, A CLEAR ROOT CAUSE WAS NOT DETERMINED. THIS IS THE FIRST OF THREE RELATED INDIVIDUAL MEDWATCH REPORTS: TWO INVOLVING TWO PT RESULTS PROVIDED BY THE CUSTOMER AS EXAMPLES OF THE RESULTS OBTAINED, AND ONE FOR MULTIPLE RESULTS REPORTED OUT OF THE LAB AND TO ACCOUNT FOR A SECOND SIMILAR EVENT WHICH THE CUSTOMER INDICATED HAD OCCURRED AT AN EARLIER TIME. THIS MEDWATCH INCLUDES THE RESULTS FOR PT #1. THE RELATED MDR NUMBERS ARE AS FOLLOWS: 2050012-2011-01740, 2050012-2011-01741. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 TO (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) AND CHLORINE (CL) RESULTS WERE OBTAINED ON THEIR UNICEL DXC 800 INSTRUMENT SOON AFTER THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM HAD BEEN DECONTAMINATED BY BECKMAN COULTER'S FSE (FIELD SVC ENGINEER). FOLLOWING THE DECONTAMINATION PROCEDURE, THE ISE SYSTEM WAS CALIBRATED AND THE QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE CUSTOMER RECALIBRATED THE INSTRUMENT AND PERFORMED QC RUNS BEFORE REPEATING ANALYSIS OF THE PT SAMPLES, AND HIGHER NA AND CL RESULTS WERE OBTAINED. MULTIPLE AMENDED RESULTS WERE REPORTED OUT OF THE LAB. CUSTOMER INDICATED THAT THIS IS THE SECOND INCIDENT OF THIS NATURE THAT HAS OCCURRED, WHERE AFTER FSE HAS PERFORMED THE ISE SYSTEM DECONTAMINATION, ERRONEOUSLY LOW NA AND CL RESULTS WERE OBTAINED. PT DATA WAS PROVIDED FOR TWO PTS ONLY AND FOR ONE INCIDENT. WHILE THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNK WHETHER THERE WAS ANY MODIFICATION TO PT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK