BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1067023 · Received June 27, 2008

    Report

    Report Number
    2122870-2008-00207
    Event Type
    Other
    Date Received
    June 27, 2008
    Date of Event
    June 7, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COLLECTS SAMPLES IN LITHIUM HEPARIN TUBES. THE SPECIMEN WAS A FULL DRAW WITH NO HEMOLYSIS. THE INITIAL SAMPLING WAS DONE THROUGH THE AUTOMATION LINE. FOR REPEAT TESTING SAMPLES WERE LOADED THROUGH THE SAMPLE PRESENTATION UNIT (SPU). QC WAS WITHIN SPECIFICATIONS ON THREE DAYS IN 2009. A SYSTEM CHECK PERFORMED ABOUT ONE WEEK PRIOR AND PASSED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE CONDUCTED A DIAGNOSTIC TESTING WITH GOOD RESULTS. THE FSE INDICATED THAT PRECISION TESTING PERFORMED BY THE CUSTOMER MET SPECIFICATIONS. THE FSE VERIFIED THE INSTRUMENT PER ESTABLISHED PROCEDURES AND RESULTS PASSED WITHIN SPECIFICATIONS. PER FSE, AN APPLICATION SPECIALIST (AS) IS SCHEDULED TO WORK WITH CUSTOMER TO ADDRESS PRE-ANALYTICAL SAMPLE HANDLING ISSUES. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED ACCU TNI RESULT GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR A SINGLE PATIENT SAMPLE. A PATIENT SAMPLE WAS TESTED FOR ACCU TNI AND A RESULT OF 5.28NG/ML WAS OBTAINED. THE RESULT WAS NOT REPORTED OUT OF THE LAB. A FRESH SAMPLE WAS COLLECTED FROM THE PATIENT AND AN ACCU TNI RESULT WAS 0.05NG/ML. TWO DAYS LATER, THE ORIGINAL SAMPLE WAS RETESTED ON THE DXI 800 INSTRUMENT AND ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND ACCU TNI RESULT OF 0.05NG/ML WAS OBTAINED FROM EACH INSTRUMENT. THE 2ND SAMPLE WAS ALSO TESTED ON THE DIFFERENT INSTRUMENT, AND A RESULT OF 0.06NG/ML WAS OBTAINED. THE CUSTOMER DID NOT REPORT PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT 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