BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2211707 · Received August 5, 2011

    Report

    Report Number
    2122870-2011-02717
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 18, 2008
    Report Date
    June 20, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    Z-0914-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT AS THE FACILITY ON 06/20/2008 AND DISCOVERED THE PERI-TUBING FLATTENED WITH BLACK "SKID-LIKE MARKS" ON THE TUBING. THE FSE REPLACED THE PERI-TUBING AND THE END CAP OF THE PERISTALTIC PUMP. THE FSE REPLACED TRANSDUCERS #3 AND #4 AND ALL REAGENT PRECISION PUMPS WERE REWORKED WITH NEW VALVES. THE FSE SUCCESSFULLY VERIFIED SYSTEM CHECKS. THE UNIT CONFORMED TO THE MFR'S ESTABLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. ALL SAMPLES WERE ASSAYED VIA THE AUTOMATION LINE ON PRIMARY TUBES. THE CUSTOMER NOTED ON TROPONIN QUALITY CONTROL (QC) FAILURE ON 6/18/2008 BUT WAS WITHIN RANGE AFTER RETEST. THE ARCHIVE FILE SHOWED THREE OTHER TROPONIN QCS FAILED ON 06/19/2008, THE CUSTOMER STATED THE UNIT WAS IN NORMAL OPERATION AFTER SERVICE WAS COMPLETED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED FROM JANUARY 01, 2008 THROUGH OCTOBER 23, 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN I (ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION RANGE, FOR ONE PT INVOLVING UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ELEVATED RESULTS DID NOT CORRELATE WITH THE PT'S CLINICAL CONDITION AND QUESTIONED BY THE PHYSICIAN. THE SAMPLES WERE RETESTED ON ANOTHER DXI 800 SYSTEM AND PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS EVENT. THE CORRECTED REPORTS WERE RELEASED TO THE PHYSICIAN. THE FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND ASSESSED THE UNIT.

    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 86 YR ACCESS ACCUTNI| UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM