BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2180430 · Received July 27, 2011

    Report

    Report Number
    2050012-2011-03089
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT ERRONEOUSLY HIGH MAGNESIUM (MG) RESULTS FOR 25 PATIENT SAMPLES ASSAYED ON THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT TREATMENT BEING IMPACTED BY THE ERRONEOUSLY HIGH MG RESULTS. THE CUSTOMER REPORTED THAT QUALITY CONTROL RESULTS FOR MG WERE WITHIN THEIR ESTABLISHED RANGES PRIOR TO THE EVENT. THE CUSTOMER REPORTED THAT AN ERROR MESSAGE OF 10 CUVETTE OUT-OF-LIMITS AND AN OBSERVED LEAK FROM THE REAGENT PROBES PROMPTED THE CUSTOMER TO REVIEW THE ANALYZER RESULTS. THE MG RESULTS WERE QUESTIONED BECAUSE, THEY WERE ABOVE THE MG REFERENCE RANGE FOR THE LABORATORY. A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE DISCOVERED A FAULTY FLOAT SWITCH IN THE WASH SOLUTION CANISTER. THE CANISTER HAD RUN DRY AND WAS NEVER REFILLED WHILE THE ANALYZER HAD CONTINUED TO OPERATE. THIS CAUSED THE CUVETTE OUT-OF-LIMIT ERRORS AND ALSO ALLOWED AIR INTO THE REAGENT LINES WHICH CAUSED THE REMAINING LIQUID IN THE PROBES TO LEAK OUT. THE FSE REPLACED THE FLOAT SWITCH WHICH CORRECTED THE PROBLEM. A 20 POINT PRECISION RUN FOR MG WAS PERFORMED WITH RESULTS WITHIN THE PRECISION CLAIM FOR THE MG ASSAY. QUALITY CONTROL RESULTS FOR MG WERE WITHIN THE LABORATORY'S ESTABLISHED RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 MAGNESIUM REAGENT