BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1062400 · Received June 17, 2008

    Report

    Report Number
    2122870-2008-00187
    Event Type
    Other
    Date Received
    June 17, 2008
    Date of Event
    May 25, 2008
    Report Date
    June 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    (K)023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A BD, 13X100MM PLASTIC LITHIUM HEPARIN GEL TUBE AND WAS CENTRIFUGED ON THE AUTOMATION LINE FOR 5 MINUTES. PER CUSTOMER, THE TUBE WAS A FULL DRAW AND NO VISUAL FIBRIN OR HEMOLYSIS WAS OBSERVED. THE SAMPLE WAS NOT RE-CENTRIFUGED PRIOR TO REPEAT ANALYSIS. QC WAS IN RANGE PRIOR TO AND FOLLOWING THE EVENT. BASED ON AVAILABLE INFO THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) AND VERIFIED THE INSTRUMENT ON 05/22/08. THE FSE WAS DISPATCHED TO THE CUSTOMER'S LAB ON 05/27/08: THE FSE FOUND COUPLER TO REAGENT GRIPPER DRIVE GEAR BROKEN AND REPLACED. THE FSE RAN A DIAGNOSTIC TESTING AND QC, AND ALL RESULTS PASSED. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. 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 ACCUTNI RESULT GENERATED BY THE UNICEL. DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR A SINGLE PT. AN INITIAL ACCU TNI RESULT OF 0.55 NG/ML WAS REPORTED OUT OF THE LAB. A FRESH SAMPLE COLLECTED FROM THIS PT GAVE A RESULT OF 0.00NG/ML INITIALLY AND UPON REPEAT. THE FIRST SAMPLE WAS THEN RETESTED AND REPEATED RESULT WAS 0.00 NG/ML. THERE HAS BEEN NO REPORT OF PT INJURY, DEATH, OR CHANGE TO TREATMENT RECEIVED BY BCI TO DATE.

    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