BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2013522 · Received March 10, 2011

    Report

    Report Number
    2122870-2011-00546
    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
    LTJ
    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)(4) 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, 2050012-2011-00544 AND 2050012-2011-00545. 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 LTJ BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1