BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1277396 · Received November 11, 2008

    Report

    Report Number
    2122870-2008-00360
    Event Type
    Other
    Date Received
    November 11, 2008
    Date of Event
    October 14, 2008
    Report Date
    November 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2008, THE CUSTOMER CALLED HOTLINE REPORTING "ASPIRATION MONITORING DETECTS POSSIBLE OBSTRUCTION ERRORS". A FIELD SERVICE ENGINEER WAS DISPATCHED THE FOLLOWING DAY: THE FSE REPLACED SAMPLE PROBE, QUICK CONNECT FITTING, AND REBUILT SAMPLE PUMP. THE FSE CALIBRATED PRESSURE SENSOR AND RAN CARRYOVER AND SYSTEM CHECK. AFTER THE FSE LEFT, THE 'ASPIRATION MONITOR DETECTS POSSIBLE OBSTRUCTION" ERRORS RETURNED AND THE CUSTOMER CONTACTED THE FSE. THE FSE DID ADVISE THE CUSTOMER TO VERIFY THAT ALL SAMPLES WERE WELL SPUN AND ADEQUATE VOLUME WAS IN EACH TUBE BEFORE LOADING. THE FSE INSTRUCTED THE CUSTOMER TO DISABLE THE PROCESS MONITORING ON THE DXI. PER DXI SERVICE MANUAL: "PROCESS MONITORING MUST BE RE-ENABLED BEFORE RESUMING NORMAL OPERATIONS, BECAUSE INACCURATE AND UNFLAGGED RESULTS MAY OCCUR". THAT SAME DAY, 3 LEVELS OF QC WERE RUN FOR THE EVENING SIFT, AND AT LEAST ONE LEVEL OF QC WAS OUT OF SPECIFICATIONS. THE RESULTS WERE ACCOMPANIED WITH FLAGS "QCF" (QCF- THE QUALITY CONTROL RESULT VIOLATES ONE OR MORE QC RULES). ARCHIVE DATA DOES NOT SHOW THAT QC WAS REPEATED AGAIN UNTIL THE FOLLOWING DAY. RESULTS FOR SOME ASSAYS WERE OUT OF SPECIFICATIONS WITH THE QCF FLAGS. THE FSE RETURNED TO THE CUSTOMER'S LAB TWO DAYS LATER AND REPLACED THE WASH BUFFER WITH A NEW LOT OF WASH BUFFER AND THE ERRORS WERE RESOLVED. HARDWARE ISSUES MAY HAVE CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED ERRONEOUSLY LOW RESULTS ON MULTIPLE PT SAMPLES FOR MULTIPLE ASSAYS RAN ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM OVER THE COURSE OF ONE DAY. SOME OF THE PT SAMPLES WERE NOT-REPRODUCIBLE WITHIN THE SAME CLINICAL RANGE. HOWEVER, A SIGNIFICANT NUMBER OF RESULTS DID CROSS DIAGNOSTIC RANGES. ON THE NEXT DAY, THE CUSTOMER RE-TESTED THE PT ORIGINAL SAMPLES AND NOTED CONSIDERABLE DIFFERENCE IN RESULTS. THESE ASSAYS INCLUDE: FERRITIN, FOLATE, PROLACTIN, AND VITAMIN B12. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. PER SERVICE SPECIALIST, TREATMENT WAS CHANGED FOR FOUR PATIENTS BASED ON THEIR ERRONEOUS FERRITIN RESULTS. NO SPECIFIC DETAILS ON THE CHANGE IN TREATMENT WERE SUPPLIED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA