BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2063661 · Received April 20, 2011

    Report

    Report Number
    2122870-2011-01055
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT INFORMATION HAS NOT BEEN SUPPLIED TO DATE. THE SAMPLES ARE COLLECTED IN 7 ML NAHEP PLASMA TUBES AND CENTRIFUGED IN THE AUTOMATION LINE CENTRIFUGE AT 3000RPM FOR 6 MINUTES. QC IS PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED LIMITS. THE CUSTOMER DOES NOT RUN SYSTEM CHECK AFTER MAINTENANCE IS PERFORMED AND ONLY IF IT IS RECOMMENDED BY TECHNICAL SUPPORT. SYSTEM CHECK HAD NOT BEEN RUN PRIOR TO THIS EVENT. HOTLINE INSTRUCTED THE CUSTOMER TO RUN SYSTEM CHECK ON THEIR INSTRUMENTS. SYSTEM CHECK FAILED ON BOTH OF THE CUSTOMERS INSTRUMENTS. HOTLINE INSTRUCTED THE CUSTOMER TO REPLACE SOME PROBES AND REPEAT SYSTEM CHECK RUNS ON BOTH INSTRUMENTS, THE RESULTS DID PASS WITHIN INSTRUMENT SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) NOTED THAT THE INSTRUMENT WAS OVERDUE FOR A PM. THE FSE COMPLETED A MODIFIED PM AND DID NOT NOTE ANY ISSUES. FSE STATED THE FOLLOWING: ASPIRATE PROBE PERISTALTIC PUMP TUBING WAS ALMOST COMPLETELY FLAT, THIS IS BELIEVED TO BE THE MAJOR CONTRIBUTOR TO THE ERRATIC RESULTS. THE TUBING WAS REPLACED AND HARDWARE WAS VERIFIED PER ESTABLISHED PROCEDURES AND SPECIFICATIONS. ALTHOUGH SOME MINOR HARDWARE ISSUES WERE ADDRESSED AT THE TIME OF SERVICE, A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH CKMB RESULT ABOVE THE NORMAL REFERENCE RANGE FOR ONE PATIENT GENERATED BY UNICEL DXI 800 ACCESSS CHEMISTRY ANALYZER. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON AN ALTERNATE UNIT AND PRODUCED LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE WAS OBTAINED. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION 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