BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER

    MDR report key: 1182444 · Received September 12, 2008

    Report

    Report Number
    2050012-2008-00050
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    August 18, 2008
    Report Date
    September 12, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THEY DID NOT SEE ANY QC PROBLEMS DURING THIS TIME AND SUCCESSFUL CALIBRATIONS WERE PERFORMED ON THE DAY OF THE EVENT. QA DID NOT RECEIVE ANY PRINTOUTS FROM CUSTOMER TO REVIEW. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: FSE CHANGE MODULAR CHEMISTRY (MC) SAMPLE PROBE AND PERFORMED ALIGNMENTS. FSE INSPECTED SYRINGE AND CREATININE MODULE FOR LEAKS. FSE CALIBRATED OBSTRUCTION DETECTION TRANSDUCER, PERFORMED PRECISION RUN AND PASSED SPECIFICATIONS. THE NEXT DAY THERE WERE GLUCOSE AND PHOSPHORUS INTERMITTENT FLAGGING ERRORS AND FSE WAS DISPATCHED: FSE INSPECTED BOTH MODULES FOR LEAKS AND ALIGNMENTS AND PROPER MOTOR FUNCTIONS. NO PROBLEMS WERE SEEN. PER CUSTOMER IN 2008, NO OTHER PROBLEMS HAVE BEEN SEEN SINCE SERVICE WAS DISPATCHED. CUSTOMER WAS EDUCATED ABOUT PREANALYTICAL VARIABLE REGARDING BLOOD TUBE DRAWS, SPIN TIME AND ALSO CLEANLINESS OF THE SAMPLE PROBE. CUSTOMER WILL RE-EVALUATE MAINTENANCE SCHEDULE. IN EVENT OF RECUR, ANY MC CHEMISTRY RESULT COULD BE AFFECTED. TREATMENT INITIATED OR WITHHELD BASED ON ERRONEOUS RESULTS COULD CONTRIBUTE TO SERIOUS INJURY. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUS CREATININE (CRE) RESULT PRODUCED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER FOR ONE PATIENT. THE ORIGINAL RESULT FOR CRE WAS 13.6MG/DL AND WAS QUESTIONED BY THE PHYSICIAN BECAUSE IT DID NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. THE SAMPLE WAS REPEATED ON A DIFFERENT ANALYZER AND THE RESULT WAS 1.2MG/DL. THE RESULT WAS AMENDED. THERE WAS NO CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA