BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2030111 · Received March 26, 2011

    Report

    Report Number
    2122870-2011-00802
    Event Type
    Malfunction
    Date Received
    March 26, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    Z-0607-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED SEVERAL ERROR MESSAGES OF REAGENT PACK MONITORING HAS DETECTED REAGENT DISPENSE FAILURE. WHILE TROUBLESHOOTING WITH HOTLINE THE CUSTOMER DISCOVERED FRT4 REAGENT PACK HAD BEEN USED ON BOTH OF THEIR DXI 800 SYSTEMS. THREE LEVELS OF QC WERE TESTED ON THIS PACK TWICE AND NONE WERE FLAGGED AS OUT OF SPECIFICATIONS IN THE DIAGNOSTIC COPY TO DISK DATA. CUSTOMER STATED THE INSTRUMENT STOPPED PROCESSING FRT4 SAMPLES DUE TO THE REAGENT PACK MONITORING ERRORS AND THE REAGENT PACK WAS DISCARDED. CUSTOMER BELIEVES THE PATIENT RESULTS FROM THIS REAGENT PACK WERE REPORTED. THE LAB HAS NOT RECEIVED ANY REPORTS OF CHANGE TO PATIENT TREATMENT OR INJURY DUE TO THIS EVENT. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS LIKELY ROOT CAUSE WAS IDENTIFIED WITH ROUTINE TROUBLESHOOTING USER ERROR IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT FREE T4 REAGENT PACK WAS SHARED BETWEEN TWO UNICEL DXI 800 ACCESS CHEMISTRY ANALYZER. PER CUSTOMER, FIFTEEN (15) PATIENT SAMPLES WERE ANALYZED ON THE SHARED REAGENT PACK. UNKNOWN IF ANY OF THE RESULTS WERE ERRONEOUS. NO RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT 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. DXI 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1