BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2161024 · Received June 17, 2011

    Report

    Report Number
    2122870-2011-01898
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    February 29, 2008
    Report Date
    March 6, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    Z-1318-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ONSITE ON (B)(4) 2008. THE FSE PERFORMED PIPETTOR ALIGNMENTS, TRANSDUCER ADJUSTMENTS, PIPETTOR MATCHING, PIPETTOR LOW VOLUME MATCHING, PRESSURE SENSOR CALIBRATIONS, AND HIGH SENSITIVITY (HS) SYSTEM CHECK AND ALL PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE FOUND OUT THAT THE INSTRUMENT USED TO RETEST THE PATIENT SAMPLE WAS USING A DIFFERENT WASH BUFFER. THE INSTRUMENT WASH BUFFER WAS SWITCHED OUT TO THE NEW WASH BUFFER. THE CUSTOMER CONFIRMED THAT THE RESULT COMPARISON BETWEEN THE TWO INSTRUMENTS WAS IMPROVED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) ON (B)(6) 2008, IN REGARDS TO ELEVATED RESULTS OBTAINED FROM A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN NORMAL REFERENCE RANGE. THE INITIAL ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PATIENT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OR INDICATION OF ANY MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI