BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2103518 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01570
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPACING BETWEEN THE PLACEMENT CLIPS OF THE PERISTALTIC TUBING WAS TOO WIDE AND WAS FOUND TO BE OUT OF SPECIFICATIONS. THE FSE FOUND THAT REACTION VESSEL ASPIRATION WAS "POOR" WITH THIS TUBING. A SYSTEM CHECK WITH HIGH WASHED % CV VALUES INDICATES AN INSUFFICIENT RV ASPIRATION. THE TUBING WAS REPLACED AND SERVICE VERIFIED SYSTEM PERFORMANCE PER PUBLISHED SPECIFICATIONS. PERI-TUBING WAS PLACED ON STOP-SHIP. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING A SERVICE CALL TO PERFORM A ROUTINE PREVENTIVE MAINTENANCE (PM) PROCEDURE ON ACCESS 2 IMMUNOASSAY SYSTEM, A FIELD SERVICE ENGINEER (FSE) FOUND THAT THE PM KIT CONTAINED PERISTALTIC TUBING THAT WAS OUT -OF-SPECIFICATIONS. NO ERRONEOUS RESULTS WERE GENERATED, AS THE INSTRUMENT HAD NOT BEEN RELEASED TO THE CUSTOMER BEFORE THE TUBING WAS REPLACED AND ALL SERVICE TESTING PASSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1