BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACESS IMMUNOASSAY SYSTEM

    MDR report key: 1059852 · Received June 10, 2008

    Report

    Report Number
    2122870-2008-00183
    Event Type
    Other
    Date Received
    June 10, 2008
    Date of Event
    May 16, 2008
    Report Date
    June 10, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT SUPPLIED. NO ERRORS WERE POSTED TO THE EVENT LOG. LABORATORY POLICY IS TO FILTER THE SAMPLE AND REPEAT ALL ACCUTNI THAT RESULT GREATER THAN 0.04NG/ML. A FIELD SERVICE ENGINEER (FSE) WAS ONSITE IN 2008: THE FSE NOTED THAT ERRONEOUS RESULTS WERE FROM MULTIPLE REAGENT PIPETTORS. THE FSE CLEANED PRECIPITANT FROM THE SEALS AND PISTON ASSEMBLY AND REPLACED THE PERI PUMP TUBING. VERIFICATION TESTING FAILED THE FIRST TWO REPS OF THE WASHED PORTION. FSE REPLACED THE ASPIRATE PROBES AND THE DUCKBILL, AND THEN THE SYSTEM CHECK PASSED. QC WAS WITHIN SPECIFICATIONS AND VERIFICATION TESTING PASSED. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, A CLEAR ROOT CAUSE 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 ERRONEOUSLY ELEVATED ACCUTNI RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR 2 PATIENTS. CUSTOMER TESTED A PATIENT SAMPLE FOR ACCUTNI AND OBTAINED A RESULT OF 0.57NG/ML. UPON REPEAT, THIS SAMPLE GAVE A RESULT OF 0.38NG/ML. A SAMPLE OBTAINED FROM ANOTHER PATIENT GAVE A RESULT OF 0.53NG/ML AND IT REPEATED AT 0.03NG/ML. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE HAS BEEN NO REPORT OF DEATH, INJURY OR CHANGE TO PATIENT TREATMENT IN ASSOCIATION TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA