BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2133047 · Received June 18, 2011

    Report

    Report Number
    2122870-2011-01895
    Event Type
    Malfunction
    Date Received
    June 18, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ERRONEOUS DATA GENERATED. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUS RESULTS FOR CARCINOEMBRYONIC ANTIGEN (CEA) FOR TWO PATIENT SAMPLES ASSAYED USING THE ACCESS CEA REAGENT ON AN ACCESS 2 IMMUNOASSAY SYSTEM. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. THE CUSTOMER REPORTED THAT THE SYSTEM CHECKS PERFORMED ON (B)(6) 2011 HAD PASSED ALL SPECIFICATIONS. IN ADDITION, QUALITY CONTROL RESULTS FROM THREE LEVELS OF QUALITY CONTROLS WERE WITHIN ESTABLISHED RANGES AT THE TIME OF THE EVENT. THE CUSTOMER INQUIRED ABOUT SAMPLE STORAGE SPECIFICATIONS WHEN ASSAYING FOR CEA. BCI COMMUNICATED TO THE CUSTOMER THAT IF IMPROPER SAMPLE STORAGE IS SUSPECTED, THEN A REDRAW OF THE PATIENT AND A REPEAT ASSAY FOR CEA IS RECOMMENDED. BCI DISPATCHED A FIELD SERVICE ENGINEER (FSE) ON (B)(4) 2011 TO THE CUSTOMER'S SITE. THE FSE REPLACED 14T BEARINGS ON THE MIXER, THE PERI-TUBING, AND THE ASPIRATE PROBES. THE FSE PERFORMED VERIFICATION ACTIVITIES AND ALL RESULTS MET PERFORMANCE SPECIFICATIONS. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS CEA REAGENT