BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3160797 · Received June 11, 2013

    Report

    Report Number
    2122870-2013-00532
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE MAIN PIPETTOR WAS BENT. THE FSE NOTED THE EVENT LOG MESSAGE INDICATED THERE WAS A PIPETTOR MOTION ERROR. THE FSE REPLACED THE MAIN PIPETTOR AND PERFORMED ALL OF THE NECESSARY ALIGNMENTS AND VERIFICATION TESTING. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED THE PRIMARY PIPETTOR WAS BENT WHILE PERFORMING WEEKLY SYSTEM MAINTENANCE ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS WITHIN SPECIFICATION, AND PATIENT RESULTS WERE NOT QUESTIONED. ALL PATIENT RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262727 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1