BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 865892 · Received June 14, 2007

    Report

    Report Number
    2122870-2007-00134
    Event Type
    Other
    Date Received
    June 14, 2007
    Date of Event
    April 30, 2007
    Report Date
    June 14, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM CHECK INFO WAS NOT SUPPLIED. QC WAS WITHIN SPECS PRIOR TO THE EVENT. THE SPECIMENS WERE COLLECTED IN GREEN TOP, 13X100 TUBES AND CENTRIFUGED AT 3,000 RPM FOR 5 MINS AT AMBIENT TEMPERATURE VIA THE AUTOMATION LINE. A FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMERS LAB. THE FSE INSPECTED THE INSTRUMENT AND DISCOVERED THAT WASH BUFFER SELECT VALVE WAS NOT WORKING. THE FSE REPLACED BOTH VALVES AND AN INTERCONNECT BOARD. THE FSE PERFORMED PIPETTOR ALIGNMENTS. THE FSE INSTALLED A NEW STYLE EJECTOR PLATE AND COMPLETED ITS ALIGNMENT. THE FSE REPLACED PERI-PUMP TUBING AND ASPIRATE PROBES. THE FSE PERFORMED: DIAGNOSTIC, PRECISION AND QC TESTING; ALL RESULTS PASSED WITHIN SPECS. HARDWARE ISSUES ADDRESSED BY THE FSE MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED IN THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT FROM A SINGLE PT SAMPLE THAT WAS GENERATED BY THE UNICEL DXL 800 ACCESS INSTRUMENT. A PT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 2.19 NG/ML WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB AND THE PT WAS ADMITTED FOR OBSERVATION ONLY. ON THE SAME DAY, A FRESH SAMPLE WAS COLLECTED FROM THE PT AND TESTED FOR ACCU TNI, AND A LOWER RESULT WAS OBTAINED (0.15 NG/ML). THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION, OR DEATH ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR