BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2281820 · Received September 30, 2011

    Report

    Report Number
    2122870-2011-04104
    Event Type
    Malfunction
    Date Received
    September 30, 2011
    Date of Event
    April 30, 2008
    Report Date
    May 2, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO INVESTIGATE THE EVENT. THE FSE FOUND THE WASH ARM PROBE PLATES OUT OF ALIGNMENT. THE FSE RE-ALIGNED THE WASH ARM PROBE PLATES. FOLLOWING THE REPAIRS THE FSE COMPLETED A 10 REPLICATE PRECISION RUN FOR ACCUTNI WITH THE LOW LEVEL QUALITY CONTROL (QC). RESULTS WERE WITHIN ACCEPTABLE RANGE. THE FSE CONCLUDED THAT HARDWARE REPAIR TO THE WASH ARM PROBE PLATE WAS IN THE ROOT CAUSE OF THIS EVENT. MDR # 2122870-2008-167 DOCUMENTS THE RESULTS FOR PT 1. THIS IS 3 OF 18 SEPARATE MDR REPORTS RELATED TO 18 PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS 212870-2011-04104, 04105, 04106, 04107, 04108, 04109, 04110, 04111, 04112, 04113, 04114, 04115, 04116, 04117, 04118, 04119 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCU TNI (TROPONIN I) RESULTS GENERATED ON A UNICEL DXI 800 IMMUNOASSAY SYSTEM FOR EIGHTEEN PTS. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER RE-RAN THE SAMPLES AND THE RESULTS WERE WITHIN NORMAL REFERENCE RANGE. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PT TREATMENT. THERE IS NO INDICATION OF AN ADVERSE EVENT OF 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