BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 824020 · Received January 29, 2007

    Report

    Report Number
    2122870-2007-00023
    Event Type
    Other
    Date Received
    January 29, 2007
    Date of Event
    January 5, 2007
    Report Date
    January 29, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC AND SYSTEM CHECK INFO HAVE NOT BEEN PROVIDED. THE SPECIMEN WAS COLLECTED IN BD, LITHIUM HEPARIN TUBE WITHOUT GEL SEPARATORS. A FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB. THE FSE PERFORMED DIAGNOSTIC AND PRECISION TESTING, AND CONDUCTED PIPETTOR VERIFICATIONS; ALL RESULTS PASSED WITHIN SPECS. THE FSE HAD BIO-MEDICAL ENGINEER VERIFY CENTRIFUGE SPEED WHICH MET SPECS. THE BECKMAN COULTER INC. (BCI) APPLICATIONS SPECIALIST (AS) REVIEWED WITH THE CUSTOMER PRE-ANALYTICAL SAMPLE HANDLING PROCESS. THE CUSTOMER IS CONSIDERING USING SEPARATOR TUBES AND/OR FILTERS IN THE FUTURE. ALTHOUGH PRE-ANALYTICAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT, 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 HIGH TROPONIN (ACCU TNI) RESULT FROM A SINGLE PT SAMPLE THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS INSTRUMENT. A PT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 0.55NG/ML WAS OBTAINED. THE RESULT WAS REPORTED OUT OF THE LAB AND QUESTIONED BY A PHYSICIAN. THE ORIGINAL SAMPLE WAS RETESTED ON THE SAME DAY, AND THE REPEATED ACCU TNI RESULT WAS 0.04NG/ML. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT THAT CAN BE ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA