BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2861687 · Received December 7, 2012

    Report

    Report Number
    2122870-2012-01966
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT ERRONEOUS PROSTATE SPECIFIC ANTIGEN (PSA), TOTAL T4, AND T UPTAKE RESULTS WERE GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR THREE PATIENTS. THE DUPLICATE RESULTS WERE NOT CONSISTENT. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY OR CHANGE TO PATIENT TREATMENT IN CONNECTION TO THIS EVENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED PRECISION PUMP SEALS TO ADDRESS THE IMPRECISION ISSUES REPORTED BY THE CUSTOMER. THE FSE THEN OBSERVED CLOUDINESS WITHIN THE INSTRUMENT WASH PUMP AND REPLACED THE ENTIRE WASH PUMP. THE FSE PERFORMED SYSTEM CHECK AND PRECISION RUNS ON THE AFFECTED ASSAYS AND OBTAINED ACCEPTABLE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1