BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3223180 · Received July 12, 2013

    Report

    Report Number
    2122870-2013-00611
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) CLEANED VALVES AND PUMP ROTORS AND STATOR. THE FSE REPLACED PIPETTOR #4 AND PERFORMED ULTRASONIC ADJUSTMENTS FOR PIPETTOR #4. THE FSE ADJUSTED ALL PIPETTOR ALIGNMENTS FOR Z-HEIGHT, CARRIAGE, AND REAGENT PACKS. THE FSE PRIMED THE FLUIDICS AND THE CUSTOMER CALIBRATED CORTISOL AND AFP ASSAY (WITH NEW CALIBRATORS/REAGENT PACK FOR AFP); ALL PASSED WITHIN SPECIFICATIONS. THE CUSTOMER PERFORMED 20-REPETITION SAMPLE PRECISION TEST FOR PIPETTOR #4. THE CUSTOMER PERFORMED QUALITY CONTROL (QC) PANEL AND ALL RESULTS WERE WITHIN RANGE. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILING ALPHA-FETOPROTEIN (AFP) AND GI (GASTROINTESTINAL) MONITOR (CA 19-9) QUALITY CONTROL (QC) RESULTS INVOLVING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM USED IN CONJUNCTION WITH THE ACCESS GI MONITOR AND ACCESS AFP ASSAYS AND CALIBRATORS. THE CUSTOMER RECALIBRATED THE ASSAY ON (B)(6) 2013 WITH THE SAME REAGENT AND CALIBRATOR AND NOTED RECALIBRATION ON (B)(6) 2013 WAS SIGNIFICANTLY DEPRESSED BY APPROXIMATELY 45-48%. THE CUSTOMER INDICATED THE CALIBRATION CURVE FOR AFP WAS PERFORMED ON PIPETTOR #4 AND NOTED THE CURVE ON THIS PIPETTOR WAS RECOVERING SIGNIFICANTLY LOW. BECKMAN COULTER CUSTOMER TECHNICAL SPECIALIST (CTS) GUIDED THE CUSTOMER IN DISABLING PIPETTOR #4. BECKMAN COULTER ALSO ADVISED THE CUSTOMER TO RETEST ANY PATIENT SAMPLES PRODUCED ON PIPETTOR #4 FOR RESULTS ACCURACY VERIFICATION. QC PERFORMANCE ON PIPETTOR #4 WAS FAILING OUT OF RANGE LOW (UP TO APPROXIMATELY 5 STANDARD DEVIATION) WHILE QC WAS PASSING WITHIN THE 2 STANDARD DEVIATION RANGE ON AN ALTERNATE UNICEL DXI 800 PIPETTORS. THE CUSTOMER STATED NO ERRONEOUS PATIENT RESULTS WERE GENERATED. PATIENT RESULTS WERE NOT IMPACTED. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321342 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1