BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1001713 · Received February 15, 2008

    Report

    Report Number
    2122870-2008-00048
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 25, 2008
    Report Date
    February 15, 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
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS ON THE DATE OF EVENT. THIS WAS THE ONLY SAMPLE IN QUESTION. A FIELD SVC ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S LAB AS THEY DECLINED SERVICE AND THEIR INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. NO ADD'L INFO REGARDING THIS EVENT WAS PROVIDED. 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 HIGH TROPONIN (ACCU TNI) RESULT THAT WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR A SINGLE PT SAMPLE. AN INITIAL ACCU TNI RESULT WAS 0.26NG/ML. THE SAMPLE WAS RE-TESTED AND REPEATED RESULT WAS 1.10NG/ML. THE SAMPLE WAS THEN RE-TESTED ONCE MORE AND A RESULT OF 0.29NG/ML WAS OBTAINED. THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND ACCU TNI RESULTS WERE 0.35NG/ML AND 0.30NG/ML. THE ACCU TNI RESULTS WERE NOT REPORTED OUT OF THE LAB. 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 JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA