BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2183629 · Received July 8, 2011

    Report

    Report Number
    2050012-2011-02853
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    January 25, 2010
    Report Date
    January 28, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE SITE AND FOUND THAT THE MODULE WAS PERFORMING CORRECTLY. THE CUSTOMER HAD RUN A PRECISION RUN OF BUNM AFTER THE INCIDENT AND THE RESULTS WERE GOOD. THE FSE FOUND THAT THERE WERE NO SYSTEM ISSUES AND THE QC (QUALITY CONTROL) WAS NOT AFFECTED. THE FSE ADVISED THE CUSTOMER THAT FIBRIN MAY HAVE ACCUMULATED IN THE CUP AND THEN GRADUALLY GOT FLUSHED OUT AS MORE SAMPLES RAN THROUGH THE MODULE. HOWEVER, A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. THE CUSTOMER HAS PUT IN PLACE AN LIS (LABORATORY INFORMATION SYSTEM) RULE TO NOT VALIDATE THE RESULTS FOR WHICH THE BUNM/CREATININE RATIO IS OUT OF RANGE. THIS IS ONE OF 15 SEPARATE MEDWATCH REPORTS RELATED TO THIS EVENT. ALL ASSOCIATED REPORTS, INCLUDING THIS ONE, ARE LISTED BELOW: 2020012-2010-02776, 02845, 02847, 02849, 02851, 02855, 02857, 02844, 02846, 02848, 02850, 02852, 02854, 02856. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED FROM (B)(6) 2008 THROUGH (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT ERRONEOUSLY HIGH UREA NITROGEN (BUNM) RESULTS WERE OBTAINED ON THEIR UNICEL DXC 800 SYNCHRON SYSTEM INSTRUMENT AND THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE ELEVATED BUNM RESULTS RANGE FROM 50-75 MG/DL. THE CUSTOMER INDICATED THAT SINCE THE ASSOCIATED CREATININE (CREM) RESULTS WERE NORMAL, THE AUTOVALIDATION HAD PASSED AND FOR THIS REASON THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE BUNM RESULTS AND THE LAB RE-RAN THE PATIENT SAMPLES. THE REPEATED BUNM RESULTS WERE LOWER, RANGING FROM 7-30 MG/DL (NORMAL RANGE), AND AMENDED REPORTS WERE SENT OUT TO PHYSICIANS. THE CUSTOMER OBSERVED INSUFFICIENT SERUM LEVELS IN THE GEL SEPARATOR TUBES DUE TO THE POWER PROCESSOR REMOVING ALIQUOTS FOR TESTING ON OTHER ANALYTES. THE CUSTOMER PROVIDED THE 15 ERRONEOUSLY HIGH BUNM RESULTS ALONG WITH THE CORRECTED RESULTS, AND THE ORIGINAL CREM RESULTS. 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK