BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2087571 · Received May 12, 2011

    Report

    Report Number
    2122870-2011-01367
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 15, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) NOTICED DILUTION FACTOR FOR PIPETTOR #4 WAS 220 COMPARED TO THE OTHER PIPETTORS THAT HAD FACTORS OF 182-189. THE FSE CHANGED THE RED AND WHITE FITTINGS FOUND IN THE REAGENT PUMP FOR PIPETTOR #4. THE CHANGING OF THESE FITTINGS RESOLVED THE IMPRECISION AND BROUGHT THE DILUTION FACTOR FOR PIPETTOR #4 INTO RANGE WITH THE OTHER PIPETTORS. THE FSE VERIFIED THE INSTRUMENT TO PUBLISHED SPECIFICATIONS. HARDWARE HAS BEEN DETERMINED TO BE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    DURING INSTALL, A BECKMAN COULTER INC., (BCI) APPLICATIONS REPRESENTATIVE CONTACTED BCI TO REPORT IMPRECISION ON UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM ON PIPETTOR #4. THE INSTRUMENT HAD NOT BEEN RELEASED TO CUSTOMER AND WAS NOT GENERATING RESULTS. NO ERRONEOUS RESULTS WERE REPORTED BY CUSTOMER.

    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. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1