BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1003383 · Received February 19, 2008

    Report

    Report Number
    2122870-2008-00057
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 19, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, QC WAS ACCEPTABLE. THE SPECIMENS WERE PLASMA TYPE WITH LITHIUM HEPARIN, COLLECTED IN GREINER VACUETTE TUBES. ALTHOUGH CENTRIFUGATION PARAMETERS WERE NOT PROVIDED, THE CUSTOMER WAS NOT AWARE OF THE 15 MIN SPIN TIME RECOMMENDATION PER GREINER INFO. A FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE REPLACED AN ASPIRATE PROBE #2, DUE TO A BUILD UP ON AN EXTERIOR. THE FSE PERFORMED A SYSTEM CHECK WHICH PASSED WITHIN SPECS. THE FSE RAN A 50-REPETITION OF TROPONIN PRECISION TEST AND OBTAINED RESULTS WITHIN EXPECTED LIMITS. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES, AND RESULTS MEET PUBLISHED PERFORMANCE SPECS. ALTHOUGH PRE-ANALYTICAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED. 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 ERRATIC TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR THREE (3) PTS. PT A: AN INITIAL ACCU TNI RESULT WAS 0.71 NG/ML AND 0.49 NG/ML UPON REPEAT. PT B: INITIAL SAMPLE FROM THIS PT GAVE A RESULT OF 0.09 NG/ML. THE ORIGINAL SAMPLE WAS RE-TESTED FOR ACCU TNI SEVERAL TIMES AND REPEATED RESULTS WERE: 1.72 NG/ML, 0.10 NG/ML, AND 0.07 NG/ML. PT C: AN INITIAL ACCU TNI RESULT WAS 0.07 NG/ML. THE SAMPLE WAS RE-TESTED TWICE AND REPEATED RESULTS WERE: 0.64 NG/ML AND 0.07 NG/ML. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB AS CUSTOMER HAS AN ESTABLISHED REPEAT PROTOCOL. THERE HAS BEEN NO REPORT OF DEATH, INJURY, OR CHANGE TO PT TREATMENT HAS OCCURRED IN ASSOCIATION TO 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