BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2913762 · Received January 14, 2013

    Report

    Report Number
    2122870-2013-00021
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 16, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    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) PERFORMED PREVENTIVE MAINTENANCE (PM-C) AND REPLACED THE SUBSTRATE PUMP AND SUBSTRATE PROBE. THE FSE NOTED VERIFICATION AND CARRYOVER TESTS PASSED WITH PUBLISHED SPECIFICATIONS. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILED CARRYOVER PROCEDURE INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER INDICATED BUFFER BASELINE PASSED BUT THE FIRST REPETITION FOLLOWING STRAIGHT SYSTEM CHECK FAILED WITH HIGH RELATIVE LIGHT UNITS (RLU'S). NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED QUALITY CONTROL (QC) WAS WITHIN SPECIFICATION. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSTRUMENT UNTIL THE ISSUE IS RESOLVED. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20506 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1