BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2183433 · Received July 28, 2011

    Report

    Report Number
    2122870-2011-02623
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 1, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE COLLECTION OR CENTRIFUGATION DATA WAS SUPPLIED BY THE CUSTOMER. CUSTOMER PRODUCT LINE SUPPORT (CPLS) INVESTIGATED THIS ISSUE AND DETERMINED THAT THE ORIGINAL REAGENT PACK (S/N (B)(4)) WAS CONTAMINATED AFTER BEING PUT INTO USE. THE CUSTOMER DID NOT INDICATE THAT SERVICE WAS DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) IN REGARDS TO OBTAINING HIGHER THAN EXPECTED RESULTS FOR CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS ON ONE (1) PATIENT'S SAMPLE, GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM AND USED IN CONJUNCTION WITH ACCESS CEA REAGENT PACK (LOT # 195028 S/N (B)(4)). THE CUSTOMER ALSO REPORTED THAT THE CEA QC WAS RECOVERING HIGH (>2 STANDARD DEVIATION). REVIEW OF THE ARCHIVE DATA FILE INDICATES THE S0 RLUS WERE 15 TIMES HIGHER THAN THE QC RELEASE DATA. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER RECALIBRATED ON A NEW REAGENT PACK (S/N (B)(4)) FROM THE SAME LOT. THE QC RECOVERED WITHIN EXPECTED RANGES AND THE PATIENT'S SAMPLE WAS REPEATED, RESULTING WITHIN THE NORMAL REFERENCE INTERVAL. 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