BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1246408 · Received November 20, 2008

    Report

    Report Number
    2122870-2008-00380
    Event Type
    Other
    Date Received
    November 20, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 20, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A LITHIUM HEPARIN TUBE WITH GEL. QC WAS WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK PERFORMED IN 2008, PASSED WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS PERFORMING A PREVENTIVE MAINTENANCE (PM) WHEN THE CUSTOMER REPORTED THIS EVENT. THE FSE NOTED DURING HARDWARE VERIFICATION THAT THE SPECIMEN WAS HEMOLYZED AND HAD A "CLUMP" IN THE TUBE. THE FSE STATED THERE WERE NO HARDWARE ISSUES. THE FSE RAN 50 REPETITIONS ON LEVEL I QC WITH NO FLYERS. NO NEW SERVICE WAS OPENED FOR THIS EVENT. ALTHOUGH FSE NOTED POOR SAMPLE QUALITY, NO CLEAR ROOT CAUSE CAN BE DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (INC) REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PT. A PT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 1.17NG/ML WAS OBTAINED. THE RESULT WAS NOT REPORTED OUT OF THE LAB. THE ORIGINAL SAMPLE WAS RE-TESTED TWICE AND RESULTS WERE 0.43NG/ML AND 0.33NG/ML. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA