BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2183605 · Received July 8, 2011

    Report

    Report Number
    2050012-2011-02840
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    December 7, 2008
    Report Date
    December 8, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FSE (FIELD SERVICE ENGINEER) WAS NOT DISPATCHED TO THE SITE SINCE ONE WAS NOT REQUESTED BY THE CUSTOMER . THE BCI HOTLINE PROVIDED INSTRUCTIONS TO THE CUSTOMER ON HOW TO PERFORM ROUTINE ISE MAINTENANCE. RECALIBRATION OF THE FIRST ANALYZER RESOLVED THE PROBLEM. HOWEVER, A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. THIS IS ONE OF 13 SEPARATE MEDWATCH REPORTS RELATED TO THIS EVENT. ALL ASSOCIATED REPORTS, INCLUDING THIS ONE, ARE LISTED BELOW: 2050012-2010-02183, 02560, 02562, 02564, 02839, 02841, 02843, 02559, 02561, 02563, 02830, 02842. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED FROM JANUARY 1, 2008 THROUGH OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) AND CHLORINE (CI) RESULTS WERE OBTAINED ON THEIR UNICEL DXC 800 SYNCHRON SYSTEM INSTRUMENT AND THE RESULTS WERE REPORTED OUT OF THE LABORATORY. PRIOR TO THE EVENT, THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WAS CALIBRATED AND QC (QUALITY CONTROL) RESULTS WERE FOUND TO BE WITHIN THE LAB'S ESTABLISHED RANGES. WHEN THE LOW RESULTS WERE QUESTIONED, THE SAMPLES WER ANALYZED ON THE LAB'S SECOND ANALYZER, BOTH THE NA AND CI RESULTS WERE FOUND TO BE HIGHER AND AMENDED REPORTS WERE ISSUED. THE ISE SYSTEM ON THE FIRST ANALYZER WAS RECALIBRATED, QC WAS RUN AND THE SAMPLES WERE RE-ANALYZED. THE RESULTS OBTAINED ON THE FIRST ANALYZER MATCHED THOSE OF THE SECOND ANALYZER. THE CUSTOMER PROVIDED 13 EXAMPLES OF THE ERRONEOUSLY LOW RESULTS ALONG WITH THE CORRECTED RESULTS. THE TOTAL NUMBER OF PATIENT SAMPLE RESULTS REPORTED OUT OF THE LABORATORY IS UNKNOWN. WHILE THE CUSTOMER DID NOT RECEIVE ANY REPORT OF ANY ADVERSE EVENT OR PATIENT INJURY ASSOCIATED WITH THIS EVENT, IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR