BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 1000762 · Received February 18, 2008

    Report

    Report Number
    2122870-2008-00054
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    February 3, 2008
    Report Date
    February 18, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    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 AND SYSTEM CHECK RESULTS HAVE NOT BEEN PROVIDED. THE SPECIMENS WERE COLLECTED IN SODIUM HEPARIN TUBES. PER CUSTOMER, ONCE THEY RE-CENTRIFUGED THE SAMPLES THEY OBTAINED RESULTS WHICH CORRELATED WITH THE CLINICAL PRESENTATION OF THE PATIENT. CUSTOMER STATED THEY DID NOT REPORT ANY ERRONEOUS RESULTS OUT OF THE LAB, AND THAT THEY ARE AWARE OF PRE-ANALYTICAL SAMPLE HANDLING ISSUES AND HOW IT CAN AFFECT PATIENT RESULTS. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S LAB AS THEY DECLINED SERVICE. CUSTOMER STATED THE ANALYZER WAS PERFORMING WITHIN SPECIFICATIONS AND THEY BELIEVED THIS EVENT WAS DUE TO SAMPLE HANDLING. ALTHOUGH PRE-ANALYTICAL SAMPLE HANDLING 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 ERRONEOUSLY HIGH TROPONIN (ACCU TNI) RESULTS THAT WERE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TWO PATIENTS. PATIENT A: AN INITIAL ACCU TNI RESULTS WAS 1.75NG/ML. ON THE SAME DAY, THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND ACCU TNI RESULTS WERE IN THE RANGE OF 0.35NG/ML-0.90NG/ML. THE SAMPLE ALIQUOT WAS RE-CENTRIFUGED AND THEN RE-TESTED ON THE UNICEL DXI 800 INSTRUMENTED AND A RESULT OF 0.12NG/ML WAS OBTAINED. THE SAMPLE ALIQUOT WAS ALSO TESTED ON A DIFFERENT INSTRUMENT AND RESULTS WERE: 0.19NG/ML AND 0.22NG/ML. THE RESULT OF 0.19NG/ML WAS REPORTED OUT OF THE LAB. PATIENT B: INITIAL ACCU TNI RESULTS WERE: 2.16NG/ML AND 0.76NG/ML. THE SAMPLE WAS TESTED ON A DIFFERENT INSTRUMENT AND ACCU TNI RESULTS OF 1.99NG/ML AND 0.41NG/ML WERE OBTAINED. THE SAMPLE ALIQUOT WAS RE-CENTRIFUGED AND THEN RE-TESTED ON BOTH INSTRUMENTS: THE UNICEL DXI 800 INSTRUMENT GAVE 2 RESULTS OF 0.05NG/ML, AND THE DIFFERENT INSTRUMENT RESULTS WERE: 0.04NG/ML AND 0.09NG/ML. IT IS UNKNOWN WHICH RESULTS WERE REPORTED FOR THIS PATIENT. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA