BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2013586 · Received March 10, 2011

    Report

    Report Number
    2122870-2011-00544
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS SERUM. THE CUSTOMER IS A REFERENCE LABORATORY, ALL SAMPLES ARE COLLECTED AND PROCESSED OFF-SITE.PER CUSTOMER, QC WAS ACCEPTABLE PRIOR TO AND AFTER THE EVENT.A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE (B)(6) 2011. FSE REPLACED THE SAMPLE PIPETTOR PROACTIVELY BECAUSE IT LOOKED OLD. FSE ALSO STATED THE CUSTOMER'S SYSTEM CHECKS WERE ALL PASSING WITHIN SPECIFICATIONS.A CLEAR ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE NEGATIVE RESULTS FOR HYBRITECH PSA RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENTS.THE RESULTS FOR THE PATIENT WERE REQUESTED BUT NOT PROVIDED BY THE CUSTOMER. THE DATA FOR THE OTHER PATIENTS ARE DOCUMENTED IN MDR #S 2050012-2011-00543, 2050012-2011-00545 AND 2050012-2011-00546. IT IS UNKNOWN IF THERE WAS ANY CHANGE TO PATIENT TREATMENT IN CONNECTION WITH 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1