BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2252743 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-04314
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    December 14, 2009
    Report Date
    December 15, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE SITE AND FOUND THAT THE CUSTOMER HAD ALREADY CLEANED THE FLOW CELL AND RECALIBRATED THE SYSTEM. THE FSE DID NOT MAKE ANY REPAIRS OR REPLACE ANY PARTS. HOWEVER, HE DID CONFIRM THAT THE ISE SYSTEM WAS OPERATING WITHIN SPECIFICATIONS. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. THIS IS 1 OF 119 INDIVIDUAL MEDWATCH REPORTS WHICH ARE RELATED TO THIS EVENT, IN ADDITION TO ONE THAT WAS SUBMITTED EARLIER IN 2009 (I.E. MEDWATCH NUMBER: 2050012-2009-00147), WHICH ACCOUNT FOR A TOTAL OF 120 PT RESULTS THAT WERE REPORTED OUT OF THE LAB. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 TO (B)(4), 2010 FOR ADD'L REPORTABLE EVENTS. THIS IS ONE OF ONE HUNDRED AND NINETEEN (119) SEPARATE MEDWATCH REPORTS BEING SUBMITTED, THAT IS RELATED TO A MEDWATCH SUBMITTED EARLIER (I.E. MDR 2050012-2009-00147), AS THIS EVENT INVOLVES 120 SEPARATE PT EVENTS THAT WERE REPORTED OUT OF THE LAB.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) RESULTS WERE OBTAINED ON THEIR UNICEL DXC 800 INSTRUMENT AND THAT THE RESULTS WERE REPORTED OUT OF THE LABORATORY. PRIOR TO THE EVENT, THE ISE (ION-SELECTIVE ELECTRODE) BUFFER AND REFERENCE REAGENTS WERE REPLACED AND THE ISE SYSTEM WAS CALIBRATED. HOWEVER, THE QC (QUALITY CONTROL) CHECK WAS NOT RUN. PT SAMPLES WERE RUN, RESULTS RANGING FROM 122-130 MMOL/L WERE OBTAINED AND REPORTED OUT OF THE LAB. WHEN A PHYSICIAN QUESTIONED THE LOW NA RESULTS, THE LAB RECALIBRATED THE ISE SYSTEM AND QC WAS RUN AND FOUND TO BE OUT OF RANGE. THE CUSTOMER CLEANED THE FLOW CELL, RECALIBRATED THE ISE SYSTEM AND RAN THE QC CHECK AGAIN. THE QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE PT SAMPLES WERE RERUN, THE REPEATED RESULTS WERE FOUND TO BE HIGHER (IN THE RANGE 134-141 MMOL/L), AND THE CUSTOMER AMENDED AND FILED 120 CORRECTED REPORTS. NO PT OR SAMPLE DATA WAS PROVIDED BY THE CUSTOMER. WHILE THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNK WHETHER THERE WAS ANY CHANGE TO PT TREATMENT.

    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