BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    MDR report key: 2032125 · Received March 28, 2011

    Report

    Report Number
    2122870-2011-00857
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN BD GOLD TOP SERUM SEPARATOR TUBE. A MINOR PREVENTIVE MAINTENANCE WAS PERFORMED ON (B)(6) 2011. QC WAS WITHIN THE ESTABLISHED RANGES. REVIEW OF THE ARCHIVE FILE SHOWED NO SYSTEM ERROR MESSAGES. SERVICE WAS ON SITE ON (B)(6) 2011. THE FIELD SERVICE ENGINEER (FSE) RAN HIGH SENSITIVITY SYSTEM CHECK, WHICH PASSED THE SPECIFICATIONS. NO HARDWARE ISSUE WAS IDENTIFIED. NO DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A HIGHER THAN EXPECTED CKMB RESULT GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. PREVIOUS AND SUBSEQUENT TESTING ON THE SAME SAMPLE PRODUCED LOWER RESULTS. THERE WAS NO REPORT OF DEATH, INJURY, 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 ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1