BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2060360 · Received April 15, 2011

    Report

    Report Number
    2122870-2011-00988
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    May 8, 2009
    Report Date
    May 8, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN GREEN-TOP PLASMA TUBES AND WERE CENTRIFUGED FOR 3 MINUTES. THE CENTRIFUGE SPEED WAS NOT PROVIDED. THERE WERE NO RESULT FLAGS OR EVENT LOG MESSAGES ASSOCIATED WITH THIS EVENT. QC PRIOR TO THE EVENT WAS WITHIN THE ESTABLISHED RANGE, BUT QC AFTER THE EVENT FAILED. CALIBRATION AFTER THE EVENT FAILED. BCI CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO STOP RUNNING PATIENT SAMPLES AND RUN A DIAGNOSTIC SYSTEM CHECK, WHICH FAILED DUE TO HIGH WASH PORTION IMPRECISION. SERVICE WAS DISPATCHED ON (B)(4) 2009. THE FIELD SERVICE ENGINEER (FSE) PERFORMED ASPIRATION TEST ON ASPIRATE PROBES AND FOUND A1 PROBE VERY SLOW. THE FSE REPLACED PERISTALTIC TUBING FOR ALL THREE PROBES AND RERAN ASPIRATION FLOW TEST AGAIN. ALL PROBES PASSED THE TEST. THE FSE PRIMED FLUIDS AND RERAN SYSTEM CHECK, WHICH PASSED SPECIFICATIONS. HARDWARE WAS THE ROOT CAUSE FOR THIS EVENT. NOTE: THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE (B)(4) 2010 - (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS/OCCURRENCES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS WITHIN THE RISK STRATIFICATION RANGE GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. A PHYSICIAN QUESTIONED ONE OF THE RESULTS AS NOT MATCHING THE CLINICAL PRESENTATION OF THE PATIENT. SUBSEQUENT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER STATED AT LEAST ONE PATIENT WAS ADMITTED. THIS REPORT IS FOR THE ADVERSE EVENT PORTION OF THIS EVENT. REPORT #2122870-2011-00987 HAS BEEN SUBMITTED FOR THE MALFUNCTION PORTION OF THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization